| Class 2 Device Recall Philips Afiniti Diagnostic Ultrasound Systems | |
Date Initiated by Firm | August 06, 2021 |
Create Date | September 17, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2484-2021 |
Recall Event ID |
88514 |
510(K)Number | K182857 |
Product Classification |
System, imaging, pulsed echo, ultrasonic - Product Code IYO
|
Product | Affiniti Diagnostic Ultrasound Systems:
Software Versions 5.0, 5.0.1 and 5.0.2
Models:
Affiniti 30 795121
Affiniti 30 795218
Affiniti 50 795208
Affiniti 50 795118
Affiniti 70 795210
Affiniti 70 795119 |
Code Information |
Afiniti Diagnostic Ultrasound Systems:
Affiniti 30
Model Number: 795121
Serial Numbers/UDI Codes
US219E1452 (01)00884838074187(21)US219E1452
US220E0262 (01)00884838074187(21)US220E0262
US320E1098 (01)00884838074187(21)US320E1098
US320E1099 (01)00884838074187(21)US320E1099
US918E0145 (01)00884838074187(21)US918E0145
USN18E0607 (01)00884838074187(21)USN18E0607
USN18E1617 (01)00884838074187(21)USN18E1617
USN19E2219 (01)00884838074187(21)USN19E2219
USN19E2220 (01)00884838074187(21)USN19E2220
USN19E2221 (01)00884838074187(21)USN19E2221
Affiniti 30
Model Number: 795218
Serial Numbers/UDI Codes
PU220E1330 N/A
PU220E1331 N/A
PU220E1332 N/A
PU220E1333 N/A
PU220E1334 N/A
PU220E1335 N/A
PU420E0442 N/A
PU420E0658 N/A
PU420E0659 N/A
PU420E0660 (01)00884838097957
PU420E0761 (01)00884838074187
PU520E0703 (01)00884838074187
PU520E0713 N/A
PU520E0854 (01)00884838074187
PU520E0855 N/A
PU520E0856 N/A
PU520E0857 N/A
PU520E0858 N/A
PU520E0859 N/A
PU520E0861 N/A
PU520E0965 N/A
PU520E0966 N/A
PU520E0967 N/A
PU520E0968 N/A
PU520E1012 N/A
PU520E1013 (01)00884838074187
PU520E1014 (01)00884838074187
PU520E1015 N/A
PU520E1016 N/A
PU520E1017 (01)00884838074187
PU520E2820 (01)00884838097957
PU520E2821 (01)00884838097957
PU520E2831 (01)00884838097957
PU620E0090 (01)00884838097957
PU720E0464 (01)00884838074187
PU720E0468 N/A
PU720E0611 (01)00884838097957
PU720E0800 (01)00884838097957
PU720E0801 (01)00884838097957
PU720E0803 N/A
PU720E0804 N/A
PU820E0248 N/A
PU820E0249 N/A
PU820E0347 (01)00884838097957
PU820E0349 N/A
PU820E0525 N/A
PU820E0526 N/A
PU820E0535 N/A
PU820E0536 N/A
PU820E0540 N/A
PU820E0541 N/A
PU820E0544 (01)00884838074187
PU820E0545 N/A
PU820E0654 (01)00884838074187
PUD19E0772 N/A
PUD19E0832 N/A
PUD19E0833 N/A
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USN19E1452 (01)00884838074187(21)USN19E1452
USN19E1453 (01)00884838074187(21)USN19E1453
USN19E1569 (01)00884838074187(21)USN19E1569
USN19E1623 (01)00884838074187(21)USN19E1623
USN19E1624 (01)00884838074187(21)USN19E1624
USN19E1625 (01)00884838074187(21)USN19E1625
USN19E1633 (01)00884838074187(21)USN19E1633
USN19E1634 (01)00884838074187(21)USN19E1634
USN19E1753 (01)00884838074187(21)USN19E1753
USN19E1754 (01)00884838074187(21)USN19E1754
USN19E1814 (01)00884838074187(21)USN19E1814
USN19E1815 (01)00884838074187(21)USN19E1815
USN19E1816 (01)00884838074187(21)USN19E1816
USN19E1915 (01)00884838074187(21)USN19E1915
USN19E1916 (01)00884838074187(21)USN19E1916
USN19E1917 (01)00884838074187(21)USN19E1917
USN19E1918 (01)00884838074187(21)USN19E1918
USN19E1919 (01)00884838074187(21)USN19E1919
USN19E1937 (01)00884838074187(21)USN19E1937
USN19E1938 (01)00884838074187(21)USN19E1938
USN19E1939 (01)00884838074187(21)USN19E1939
USN19E1940 (01)00884838074187(21)USN19E1940
USN19E1941 (01)00884838074187(21)USN19E1941
USN19E1942 (01)00884838074187(21)USN19E1942
USN19E2117 (01)00884838074187(21)USN19E2117
USN19E2137 (01)00884838074187(21)USN19E2137
USN19E2138 (01)00884838074187(21)USN19E2138
USN19E2139 (01)00884838074187(21)USN19E2139
USN19E2203 (01)00884838074187(21)USN19E2203
USN19E2216 (01)00884838074187(21)USN19E2216
USN19E2223 (01)00884838074187(21)USN19E2223
USN20E1214 (01)00884838074187(21)USN20E1214
USN20E1615 (01)00884838074187(21)USN20E1615
USN20E1689 (01)00884838074187(21)USN20E1689
USN20E2096 (01)00884838074187(21)USN20E2096
USN20E2097 (01)00884838074187(21)USN20E2097
USO19E0048 (01)00884838074187(21)USO19E0048
USO19E0049 (01)00884838074187(21)USO19E0049
USO19E0308 (01)00884838074187(21)USO19E0308
USO19E0309 (01)00884838074187(21)USO19E0309
USO19E0310 (01)00884838074187(21)USO19E0310
USO19E0311 (01)00884838074187(21)USO19E0311
USO19E0312 (01)00884838074187(21)USO19E0312
USO19E0313 (01)00884838074187(21)USO19E0313
USO19E0315 (01)00884838074187(21)USO19E0315
USO19E0647 (01)00884838074187(21)USO19E0647
USO19E0648 (01)00884838074187(21)USO19E0648
USO19E0649 (01)00884838074187(21)USO19E0649
USO19E0923 (01)00884838074187(21)USO19E0923
USO19E0924 (01)00884838074187(21)USO19E0924
USO19E0925 (01)00884838074187(21)USO19E0925
USO19E0987 (01)00884838074187(21)USO19E0987
USO19E1032 (01)00884838074187(21)USO19E1032
USO19E1587 (01)00884838074187(21)USO19E1587
USO19E1588 (01)00884838074187(21)USO19E1588
USO19E1589 (01)00884838074187(21)USO19E1589
USO19E1678 (01)00884838074187(21)USO19E1678
USO19E1680 (01)00884838074187(21)USO19E1680
USO19E1681 (01)00884838074187(21)USO19E1681
USO19E1682 (01)00884838074187(21)USO19E1682
USO19E1683 (01)00884838074187(21)USO19E1683
USO19E1714 (01)00884838074187(21)USO19E1714
USO19E1715 (01)00884838074187(21)USO19E1715
USO19E1716 (01)00884838074187(21)USO19E1716
USO19E1717 (01)00884838074187(21)USO19E1717
USO19E1801 (01)00884838074187(21)USO19E1801
USO19E1811 (01)00884838074187(21)USO19E1811
USO19E1812 (01)00884838074187(21)USO19E1812
USO19E1917 (01)00884838074187(21)USO19E1917
USO19E1918 (01)00884838074187(21)USO19E1918
USO19E1919 (01)00884838074187(21)USO19E1919
USO19E1920 (01)00884838074187(21)USO19E1920
USO19E1921 (01)00884838074187(21)USO19E1921
USO19E2003 (01)00884838074187(21)USO19E2003
USO19E2004 (01)00884838074187(21)USO19E2004
USO19E2005 (01)00884838074187(21)USO19E2005
USO19E2006 (01)00884838074187(21)USO19E2006
USO19E2007 (01)00884838074187(21)USO19E2007
USO19E2008 (01)00884838074187(21)USO19E2008
USO19E2009 (01)00884838074187(21)USO19E2009
USO19E2076 (01)00884838074187(21)USO19E2076
USO19E2206 (01)00884838074187(21)USO19E2206
USO19E2207 (01)00884838074187(21)USO19E2207
USO19E2304 (01)00884838074187(21)USO19E2304
USO19E2352 (01)00884838074187(21)USO19E2352
USO19E2353 (01)00884838074187(21)USO19E2353
USO19E2354 (01)00884838074187(21)USO19E2354
USO19E2418 (01)00884838074187(21)USO19E2418
USO19E2419 (01)00884838074187(21)USO19E2419
USO19E2420 (01)00884838074187(21)USO19E2420
USO19E2551 (01)00884838074187(21)USO19E2551
USO19E2552 (01)00884838074187(21)USO19E2552
USO19E2615 (01)00884838074187(21)USO19E2615
USO19E2616 (01)00884838074187(21)USO19E2616
USO19E2624 (01)00884838074187(21)USO19E2624
USO19E2628 (01)00884838074187(21)USO19E2628
USO19E2629 (01)00884838074187(21)USO19E2629
USO19E2630 (01)00884838074187(21)USO19E2630
USO19E2631 (01)00884838074187(21)USO19E2631
USO19E2632 (01)00884838074187(21)USO19E2632
USO19E2770 (01)00884838074187(21)USO19E2770
USO19E2775 (01)00884838074187(21)USO19E2775
USO19E2776 (01)00884838074187(21)USO19E2776
USO19E2777 (01)00884838074187(21)USO19E2777
USO19E2778 (01)00884838074187(21)USO19E2778
USO19E2779 (01)00884838074187(21)USO19E2779
USO19E2782 (01)00884838074187(21)USO19E2782
USO19E2783 (01)00884838074187(21)USO19E2783
USO19E2868 (01)00884838074187(21)USO19E2868
USO19E2869 (01)00884838074187(21)USO19E2869
USO19E2909 (01)00884838074187(21)USO19E2909
USO20E1064 (01)00884838074187(21)USO20E1064
Affiniti 50
Model Number: 795208
Serial Numbers/UDI Codes
BZ120D0069 N/A
BZ120D0177 N/A
BZ120D0179 (01)00884838056244
BZ120D0180 N/A
BZ120D0182 N/A
BZ120D0293 N/A
BZ120D0445 N/A
BZ120D0481 N/A
BZ217D0676 N/A
BZ719D1386 N/A
BZ719D1629 N/A
BZ720D0995 (01)00884838097759
BZ720D0996 (01)00884838056244
BZ720D1059 (01)00884838097759
BZ819D0890 N/A
BZ819D1052 N/A
BZ819D1147 N/A
BZ819D1205 N/A
BZ819D1206 N/A
BZ819D1211 N/A
BZ916D0335 (01)00884838056244(21)BZ916D0335
BZD18D0191 N/A
BZD18D1259 N/A
PU220D1306 N/A
PU220D1307 N/A
PU220D1308 N/A
PU220D1310 N/A
PU220D1311 N/A
PU420D0510 N/A
PU420D0511 N/A
PU420D0554 (01)00884838056244
PU420D0555 N/A
PU420D0556 (01)00884838056244
PU420D0558 N/A
PU420D0559 (01)00884838056244
PU420D0560 N/A
PU420D0561 (01)00884838056244
PU420D0562 N/A
PU420D0563 N/A
PU520D0704 (01)00884838056244
PU520D0705 N/A
PU520D0706 N/A
PU520D0707 (01)00884838056244
PU620D0013 N/A
PU620D0014 N/A
PU620D0015 N/A
PU620D0083 (01)00884838056244
PU720D0358 N/A
PU720D0452 N/A
PU720D0456 N/A
PU720D0808 N/A
PU820D0528 N/A
PU820D0529 (01)00884838056244
PU820D0645 (01)00884838056244
PU820D0647 N/A
PUD19D0827 N/A
PUD19D0828 N/A
PUD19D0835 N/A
PUD19D0836 N/A
RU220D0691 N/A
RU818D1831 (01)00884838056244(21)RU818D1831
US116D0243 N/A
US117D0146 (01)00884838056244(21)US117D0146
US117D0414 (01)00884838056244(21)US117D0414
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US120D0406 (01)00884838056244(21)US120D0406
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US120D0438 (01)00884838056244(21)US120D0438
US120D0506 (01)00884838056244(21)US120D0506
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US120D0632 (01)00884838056244(21)US120D0632
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US120D0749 (01)00884838056244(21)US120D0749
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US120D0886 (01)00884838056244(21)US120D0886
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US120D0992 (01)00884838056244(21)US120D0992
US120D0993 (01)00884838056244(21)US120D0993
US120D1062 (01)00884838056244(21)US120D1062
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US120D1146 (01)00884838056244(21)US120D1146
US120D1148 (01)00884838056244(21)US120D1148
US120D1149 (01)00884838056244(21)US120D1149
US120D1207 (01)00884838056244(21)US120D1207
US120D1219 (01)00884838056244(21)US120D1219
US120D1220 (01)00884838056244(21)US120D1220
US120D1221 (01)00884838056244(21)US120D1221
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US120D1525 (01)00884838056244(21)US120D1525
US120D1526 (01)00884838056244(21)US120D1526
US120D1529 (01)00884838056244(21)US120D1529
US120D1530 (01)00884838056244(21)US120D1530
US120D1531 (01)00884838056244(21)US120D1531
US120D1532 (01)00884838056244(21)US120D1532
US120D1570 (01)00884838056244(21)US120D1570
US120D1571 (01)00884838056244(21)US120D1571
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US120D1616 (01)00884838056244(21)US120D1616
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US120D1640 (01)00884838056244(21)US120D1640
US120D1641 (01)00884838056244(21)US120D1641
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US120D1704 (01)00884838056244(21)US120D1704
US120D1705 (01)00884838056244(21)US120D1705
US120D1706 (01)00884838056244(21)US120D1706
US120D1707 (01)00884838056244(21)US120D1707
US120D1708 (01)00884838056244(21)US120D1708
US120D1709 (01)00884838056244(21)US120D1709
US120D1710 (01)00884838056244(21)US120D1710
US120D1711 (01)00884838056244(21)US120D1711
US120D1716 (01)00884838056244(21)US120D1716
US120D1717 (01)00884838056244(21)US120D1717
US120D1718 (01)00884838056244(21)US120D1718
US120D1719 (01)00884838056244(21)US120D1719
US120D1720 (01)00884838056244(21)US120D1720
US120D1721 (01)00884838056244(21)US120D1721
US120D1809 (01)00884838056244(21)US120D1809
US120D1879 (01)00884838056244(21)US120D1879
US120D1974 (01)00884838056244(21)US120D1974
US120D1975 (01)00884838056244(21)US120D1975
US121D0974 (01)00884838056244(21)US121D0974
US215D0269 N/A
US215D0324 N/A
US216D0179 N/A
US216D0656 N/A
US216D0901 N/A
US217D0351 (01)00884838056244(21)US217D0351
US217D0473 (01)00884838056244(21)US217D0473
US217D0474 (01)00884838056244(21)US217D0474
US217D0475 (01)00884838056244(21)US217D0475
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US219D0054 (01)00884838056244(21)US219D0054
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US220D0305 (01)00884838056244(21)US220D0305
US220D0306 (01)00884838056244(21)US220D0306
US220D0350 (01)00884838056244(21)US220D0350
US220D0351 (01)00884838056244(21)US220D0351
US220D0352 (01)00884838056244(21)US220D0352
US220D0355 (01)00884838056244(21)US220D0355
US220D0356 (01)00884838056244(21)US220D0356
US220D0443 (01)00884838056244(21)US220D0443
US220D0444 (01)00884838056244(21)US220D0444
US220D0468 (01)00884838056244(21)US220D0468
US220D0791 (01)00884838056244(21)US220D0791
US220D0828 (01)00884838056244(21)US220D0828
US220D0829 (01)00884838056244(21)US220D0829
US220D0830 (01)00884838056244(21)US220D0830
US220D0831 (01)00884838056244(21)US220D0831
US220D0832 (01)00884838056244(21)US220D0832
US220D0833 (01)00884838056244(21)US220D0833
US220D0901 (01)00884838056244(21)US220D0901
US220D0956 (01)00884838056244(21)US220D0956
US220D1002 (01)00884838056244(21)US220D1002
US220D1003 (01)00884838056244(21)US220D1003
US220D1004 (01)00884838056244(21)US220D1004
US220D1053 (01)00884838056244(21)US220D1053
US220D1054 (01)00884838056244(21)US220D1054
US220D1055 (01)00884838056244(21)US220D1055
US220D1064 (01)00884838056244(21)US220D1064
US220D1084 (01)00884838056244(21)US220D1084
US220D1085 (01)00884838056244(21)US220D1085
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US220D1090 (01)00884838056244(21)US220D1090
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US220D1094 (01)00884838056244(21)US220D1094
US220D1095 (01)00884838056244(21)US220D1095
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US220D1207 (01)00884838056244(21)US220D1207
US220D1208 (01)00884838056244(21)US220D1208
US220D1209 (01)00884838056244(21)US220D1209
US220D1380 (01)00884838056244(21)US220D1380
US220D1383 (01)00884838056244(21)US220D1383
US220D1384 (01)00884838056244(21)US220D1384
US220D1385 (01)00884838056244(21)US220D1385
US220D1386 (01)00884838056244(21)US220D1386
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US220D1604 (01)00884838056244(21)US220D1604
US220D1606 (01)00884838056244(21)US220D1606
US315D1278 N/A
US315D1283 N/A
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USO19D0221 (01)00884838056244(21)USO19D0221
USO19D0316 (01)00884838056244(21)USO19D0316
USO19D0418 (01)00884838056244(21)USO19D0418
USO19D0582 (01)00884838056244(21)USO19D0582
USO19D0583 (01)00884838056244(21)USO19D0583
USO19D0584 (01)00884838056244(21)USO19D0584
USO19D0585 (01)00884838056244(21)USO19D0585
USO19D0586 (01)00884838056244(21)USO19D0586
USO19D0811 (01)00884838056244(21)USO19D0811
USO19D0812 (01)00884838056244(21)USO19D0812
USO19D0815 (01)00884838056244(21)USO19D0815
USO19D0912 (01)00884838056244(21)USO19D0912
USO19D0935 (01)00884838056244(21)USO19D0935
USO19D1582 (01)00884838056244(21)USO19D1582
USO19D1585 (01)00884838056244(21)USO19D1585
USO19D1586 (01)00884838056244(21)USO19D1586
USO19D1599 (01)00884838056244(21)USO19D1599
USO19D1600 (01)00884838056244(21)USO19D1600
USO19D1667 (01)00884838056244(21)USO19D1667
USO19D1668 (01)00884838056244(21)USO19D1668
USO19D1669 (01)00884838056244(21)USO19D1669
USO19D1705 (01)00884838056244(21)USO19D1705
USO19D1706 (01)00884838056244(21)USO19D1706
USO19D1707 (01)00884838056244(21)USO19D1707
USO19D1726 (01)00884838056244(21)USO19D1726
USO19D1727 (01)00884838056244(21)USO19D1727
USO19D1728 (01)00884838056244(21)USO19D1728
USO19D1729 (01)00884838056244(21)USO19D1729
USO19D1730 (01)00884838056244(21)USO19D1730
USO19D1803 (01)00884838056244(21)USO19D1803
USO19D1804 (01)00884838056244(21)USO19D1804
USO19D1805 (01)00884838056244(21)USO19D1805
USO19D1826 (01)00884838056244(21)USO19D1826
USO19D1911 (01)00884838056244(21)USO19D1911
USO19D1912 (01)00884838056244(21)USO19D1912
USO19D1913 (01)00884838056244(21)USO19D1913
USO19D2014 (01)00884838056244(21)USO19D2014
USO19D2015 (01)00884838056244(21)USO19D2015
USO19D2016 (01)00884838056244(21)USO19D2016
USO19D2031 (01)00884838056244(21)USO19D2031
USO19D2072 (01)00884838056244(21)USO19D2072
USO19D2120 (01)00884838056244(21)USO19D2120
USO19D2199 (01)00884838056244(21)USO19D2199
USO19D2358 (01)00884838056244(21)USO19D2358
USO19D2359 (01)00884838056244(21)USO19D2359
USO19D2360 (01)00884838056244(21)USO19D2360
USO19D2376 (01)00884838056244(21)USO19D2376
USO19D2377 (01)00884838056244(21)USO19D2377
USO19D2378 (01)00884838056244(21)USO19D2378
USO19D2505 (01)00884838056244(21)USO19D2505
USO19D2506 (01)00884838056244(21)USO19D2506
USO19D2547 (01)00884838056244(21)USO19D2547
USO19D2548 (01)00884838056244(21)USO19D2548
USO19D2549 (01)00884838056244(21)USO19D2549
USO19D2550 (01)00884838056244(21)USO19D2550
USO19D2621 (01)00884838056244(21)USO19D2621
USO19D2622 (01)00884838056244(21)USO19D2622
USO19D2623 (01)00884838056244(21)USO19D2623
USO19D2766 (01)00884838056244(21)USO19D2766
USO19D2767 (01)00884838056244(21)USO19D2767
USO19D2799 (01)00884838056244(21)USO19D2799
USO19D2867 (01)00884838056244(21)USO19D2867
USO19D2913 (01)00884838056244(21)USO19D2913
USO19D2914 (01)00884838056244(21)USO19D2914
USO19D2915 (01)00884838056244(21)USO19D2915
USO20D2118 (01)00884838056244(21)USO20D2118
Affiniti 50
Model Number: 795118
Serial Numbers/UDI Codes
US319D0387 (01)00884838056244(21)US319D0387
US519D1329 (01)00884838056244(21)US519D1329
USN18D0258 (01)00884838056244(21)USN18D0258
USN18D1294 (01)00884838056244(21)USN18D1294
USN19D0472 (01)00884838056244(21)USN19D0472
USN19D0777 (01)00884838056244(21)USN19D0777
USO19D0318 (01)00884838056244(21)USO19D0318
USO19D0569 (01)00884838056244(21)USO19D0569
Affiniti 70
Model Number: 795210
Serial Numbers/UDI Codes
BZ119F0375 N/A
BZ119F0864 N/A
BZ120F0638 N/A
BZ120F0867 N/A
BZ120F0868 N/A
BZ120F0911 N/A
BZ120F0913 N/A
BZ120F0989 N/A
BZ120F0990 N/A
BZ120F1061 N/A
BZ120F1078 N/A
BZ120F1081 N/A
BZ120F1154 N/A
BZ120F1155 N/A
BZ120F1157 N/A
BZ120F1209 N/A
BZ120F1212 N/A
BZ120F1213 N/A
BZ120F1284 N/A
BZ120F1895 N/A
BZ120F1948 (01)00884838056251
BZ120F2068 (01)00884838056251
BZ218F1111 (01)00884838056251
BZ220F1621 N/A
BZ220F1622 N/A
BZ318F1335 N/A
BZ320F0234 N/A
BZ320F1758 N/A
BZ320F1759 N/A
BZ320F1990 N/A
BZ416F0036 N/A
BZ420F0123 N/A
BZ420F0124 N/A
BZ720F1656 (01)00884838097766
BZ720F1658 (01)00884838056251
BZ720F1659 N/A
BZ720F1660 N/A
BZ720F1662 N/A
BZ720F1663 N/A
BZ720F1664 (01)00884838056251
BZ720F1665 N/A
BZ720F1736 N/A
BZ720F1737 (01)00884838097766
BZ720F1738 N/A
BZ720F1739 (01)00884838097766
BZ720F1740 (01)00884838056251
BZ720F1741 (01)00884838097766
BZ720F1743 N/A
BZ720F1774 N/A
BZ720F1775 (01)00884838056251
BZ720F1776 (01)00884838097766
BZ720F1808 N/A
BZ720F1809 N/A
BZ720F1810 (01)00884838097766
BZ720F1811 N/A
BZ720F1812 (01)00884838097766
BZ720F1813 N/A
BZ720F1814 (01)00884838097766
BZ720F1815 (01)00884838097766
BZ720F1828 N/A
BZ720F1829 (01)00884838097766
BZ720F1830 N/A
BZ720F1831 (01)00884838097766
BZ720F1832 (01)00884838097766
BZ820F0059 (01)00884838097766
BZ820F1003 (01)00884838097766
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BZ820F1005 (01)00884838097766
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BZ820F1007 (01)00884838097766
BZ820F1065 N/A
BZ820F1066 (01)00884838097766
BZ820F1067 N/A
BZ820F1068 N/A
BZ820F1145 (01)00884838097766
BZ820F1146 N/A
BZ820F1147 N/A
BZ820F1222 (01)00884838097766
BZ820F1224 (01)00884838097766
BZ820F1225 (01)00884838097766
BZ820F1304 N/A
BZ820F1305 (01)00884838097766
BZ820F1306 N/A
BZ820F1307 (01)00884838056251
BZ820F1427 N/A
BZ820F1428 (01)00884838056251
BZ918F1610 N/A
BZD18F0127 N/A
BZN18F0482 N/A
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BZN18F0590 N/A
BZN18F0801 N/A
BZN18F0902 N/A
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BZO20F1898 (01)00884838097766
BZO20F1899 (01)00884838097766
BZO20F1900 (01)00884838097766
BZO20F1901 (01)00884838097766
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BZO20F2003 (01)00884838097766
BZO20F2004 (01)00884838097766
BZO20F2005 (01)00884838097766
PU120F1540 N/A
PU120F1541 N/A
PU120F1542 N/A
PU120F1543 N/A
PU120F1544 N/A
PU120F1545 N/A
PU120F1546 N/A
PU120F1547 (01)00884838056251
PU120F1747 N/A
PU120F1748 N/A
PU120F1749 N/A
PU120F1750 N/A
PU120F1751 N/A
PU120F1752 N/A
PU120F1753 (01)00884838056251
PU220F1271 (01)00884838056251
PU220F1272 N/A
PU220F1273 N/A
PU220F1274 N/A
PU220F1275 (01)00884838056251
PU220F1277 N/A
PU220F1278 N/A
PU220F1279 N/A
PU220F1280 N/A
PU220F1281 N/A
PU220F1305 (01)00884838056251
PU420F0334 N/A
PU420F0335 (01)00884838056251
PU420F0439 N/A
PU420F0661 N/A
PU420F0662 (01)00884838097766
PU420F0663 N/A
PU420F0754 N/A
PU420F0755 N/A
PU420F0756 (01)00884838097766
PU420F0757 N/A
PU420F0758 N/A
PU520F0709 (01)00884838056251
PU520F0710 N/A
PU520F0711 (01)00884838056251
PU520F0712 (01)00884838056251
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PU520F0865 N/A
PU520F0866 (01)00884838056251
PU620F0016 N/A
PU620F0019 N/A
PU620F0021 N/A
PU620F0253 (01)00884838056251
PU620F0254 (01)00884838056251
PU620F0255 N/A
PU620F0256 (01)00884838056251
PU620F0257 N/A
PU620F0308 (01)00884838056251
PU620F0309 (01)00884838056251
PU620F0310 (01)00884838056251
PU620F0312 (01)00884838056251
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PU720F0474 (01)00884838056251
PU720F0476 (01)00884838056251
PU720F0612 (01)00884838097766
PU720F0613 (01)00884838056251
PU720F0614 N/A
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PU820F0717 (01)00884838056251
PU820F0718 (01)00884838097766
PU820F0720 (01)00884838056251
PU820F0723 N/A
PU820F0724 N/A
PU820F0746 (01)00884838056251
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PU820F0801 (01)00884838097766
PU820F0910 N/A
PU820F0913 (01)00884838056251
PU820F0916 (01)00884838097766
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RU620F1384 N/A
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USO19F1708 (01)00884838056251(21)USO19F1708
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USO19F1734 (01)00884838056251(21)USO19F1734
USO19F1798 (01)00884838056251(21)USO19F1798
USO19F1799 (01)00884838056251(21)USO19F1799
USO19F1800 (01)00884838056251(21)USO19F1800
USO19F1807 (01)00884838056251(21)USO19F1807
USO19F1808 (01)00884838056251(21)USO19F1808
USO19F1809 (01)00884838056251(21)USO19F1809
USO19F1810 (01)00884838056251(21)USO19F1810
USO19F1840 (01)00884838056251(21)USO19F1840
USO19F1845 (01)00884838056251(21)USO19F1845
USO19F1846 (01)00884838056251(21)USO19F1846
USO19F1847 (01)00884838056251(21)USO19F1847
USO19F1916 (01)00884838056251(21)USO19F1916
USO19F1992 (01)00884838056251(21)USO19F1992
USO19F1993 (01)00884838056251(21)USO19F1993
USO19F1994 (01)00884838056251(21)USO19F1994
USO19F1995 (01)00884838056251(21)USO19F1995
USO19F1996 (01)00884838056251(21)USO19F1996
USO19F1997 (01)00884838056251(21)USO19F1997
USO19F1998 (01)00884838056251(21)USO19F1998
USO19F1999 (01)00884838056251(21)USO19F1999
USO19F2017 (01)00884838056251(21)USO19F2017
USO19F2018 (01)00884838056251(21)USO19F2018
USO19F2019 (01)00884838056251(21)USO19F2019
USO19F2020 (01)00884838056251(21)USO19F2020
USO19F2021 (01)00884838056251(21)USO19F2021
USO19F2022 (01)00884838056251(21)USO19F2022
USO19F2023 (01)00884838056251(21)USO19F2023
USO19F2033 (01)00884838056251(21)USO19F2033
USO19F2034 (01)00884838056251(21)USO19F2034
USO19F2035 (01)00884838056251(21)USO19F2035
USO19F2036 (01)00884838056251(21)USO19F2036
USO19F2073 (01)00884838056251(21)USO19F2073
USO19F2075 (01)00884838056251(21)USO19F2075
USO19F2121 (01)00884838056251(21)USO19F2121
USO19F2123 (01)00884838056251(21)USO19F2123
USO19F2124 (01)00884838056251(21)USO19F2124
USO19F2125 (01)00884838056251(21)USO19F2125
USO19F2126 (01)00884838056251(21)USO19F2126
USO19F2127 (01)00884838056251(21)USO19F2127
USO19F2154 (01)00884838056251(21)USO19F2154
USO19F2200 (01)00884838056251(21)USO19F2200
USO19F2201 (01)00884838056251(21)USO19F2201
USO19F2202 (01)00884838056251(21)USO19F2202
USO19F2203 (01)00884838056251(21)USO19F2203
USO19F2204 (01)00884838056251(21)USO19F2204
USO19F2205 (01)00884838056251(21)USO19F2205
USO19F2303 (01)00884838056251(21)USO19F2303
USO19F2356 (01)00884838056251(21)USO19F2356
USO19F2379 (01)00884838056251(21)USO19F2379
USO19F2380 (01)00884838056251(21)USO19F2380
USO19F2381 (01)00884838056251(21)USO19F2381
USO19F2382 (01)00884838056251(21)USO19F2382
USO19F2383 (01)00884838056251(21)USO19F2383
USO19F2409 (01)00884838056251(21)USO19F2409
USO19F2410 (01)00884838056251(21)USO19F2410
USO19F2411 (01)00884838056251(21)USO19F2411
USO19F2412 (01)00884838056251(21)USO19F2412
USO19F2415 (01)00884838056251(21)USO19F2415
USO19F2416 (01)00884838056251(21)USO19F2416
USO19F2496 (01)00884838056251(21)USO19F2496
USO19F2497 (01)00884838056251(21)USO19F2497
USO19F2499 (01)00884838056251(21)USO19F2499
USO19F2501 (01)00884838056251(21)USO19F2501
USO19F2502 (01)00884838056251(21)USO19F2502
USO19F2503 (01)00884838056251(21)USO19F2503
USO19F2504 (01)00884838056251(21)USO19F2504
USO19F2545 (01)00884838056251(21)USO19F2545
USO19F2546 (01)00884838056251(21)USO19F2546
USO19F2586 (01)00884838056251(21)USO19F2586
USO19F2587 (01)00884838056251(21)USO19F2587
USO19F2588 (01)00884838056251(21)USO19F2588
USO19F2617 (01)00884838056251(21)USO19F2617
USO19F2618 (01)00884838056251(21)USO19F2618
USO19F2619 (01)00884838056251(21)USO19F2619
USO19F2620 (01)00884838056251(21)USO19F2620
USO19F2689 (01)00884838056251(21)USO19F2689
USO19F2763 (01)00884838056251(21)USO19F2763
USO19F2764 (01)00884838056251(21)USO19F2764
USO19F2765 (01)00884838056251(21)USO19F2765
USO19F2768 (01)00884838056251(21)USO19F2768
USO19F2769 (01)00884838056251(21)USO19F2769
USO19F2784 (01)00884838056251(21)USO19F2784
USO19F2785 (01)00884838056251(21)USO19F2785
USO19F2786 (01)00884838056251(21)USO19F2786
USO19F2787 (01)00884838056251(21)USO19F2787
USO19F2788 (01)00884838056251(21)USO19F2788
USO19F2789 (01)00884838056251(21)USO19F2789
USO19F2790 (01)00884838056251(21)USO19F2790
USO19F2791 (01)00884838056251(21)USO19F2791
USO19F2792 (01)00884838056251(21)USO19F2792
USO19F2793 (01)00884838056251(21)USO19F2793
USO19F2794 (01)00884838056251(21)USO19F2794
USO19F2795 (01)00884838056251(21)USO19F2795
USO19F2796 (01)00884838056251(21)USO19F2796
USO19F2797 (01)00884838056251(21)USO19F2797
USO19F2798 (01)00884838056251(21)USO19F2798
USO19F2916 (01)00884838056251(21)USO19F2916
USO19F2917 (01)00884838056251(21)USO19F2917
USO19F2918 (01)00884838056251(21)USO19F2918
USO19F2919 (01)00884838056251(21)USO19F2919
USO19F2920 (01)00884838056251(21)USO19F2920
USO19F2921 (01)00884838056251(21)USO19F2921
USO19F2924 (01)00884838056251(21)USO19F2924
USO19F2925 (01)00884838056251(21)USO19F2925
USO20F1789 (01)00884838056251(21)USO20F1789
Affiniti 70
Model Number: 795119
Serial Numbers/UDI Codes
US120F1622 (01)00884838056251(21)US120F1622
US215F0692 N/A
US414F0194 N/A
US419F0618 (01)00884838056251(21)US419F0618
US514F0204 N/A
US519F0207 (01)00884838056251(21)US519F0207
US714F0716 N/A
US719F1248 (01)00884838056251(21)US719F1248
US720F1570 (01)00884838056251(21)US720F1570
US720F1571 (01)00884838056251(21)US720F1571
US720F1572 (01)00884838056251(21)US720F1572
US720F1573 (01)00884838056251(21)US720F1573
US720F1574 (01)00884838056251(21)US720F1574
US814F0056 N/A
US918F1096 (01)00884838056251(21)US918F1096
USD20F1270 (01)00884838056251(21)USD20F1270
USO18F2086 (01)00884838056251(21)USO18F2086
USO19F0187 (01)00884838056251(21)USO19F0187
USO19F0188 (01)00884838056251(21)USO19F0188
USO19F0189 (01)00884838056251(21)USO19F0189
USO19F1915 (01)00884838056251(21)USO19F1915
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Recalling Firm/ Manufacturer |
Philips Ultrasound Inc 22100 Bothell Everett Hwy Bothell WA 98021-8431
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For Additional Information Contact | Holly Wright Lee 440-483-2015 |
Manufacturer Reason for Recall | Due to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. |
FDA Determined Cause 2 | Software design |
Action | On 08/06/2021, the firm sent via certified mail an "URGENT Medical Device Correction" Notification Letter to customer informing them that due to a software defect, when reviewing or adjusting xPlane exam results, there is a potential for the ultrasound systems to become unresponsive (Lock-up) preventing users from continuing clinical use. The ultrasound system provides an error notification including method to restart and bring system back to normal use. The Recalling Firm has received a report of an ultrasound system locking up multiple times during an open cardiac procedure while using a Transesophageal Echocardiogram (TEE) transducer. Each lock-up required at least one system reboot to regain functionality.
Customers are instructed to:
1) Determine the software version on their ultrasound system by:
- Power up the system and allow it to complete the boot sequence;
- Press Support on the right side of the control panel;
- Under System Management, click System Information;
- The software version is listed in the Software Information Section.
2) Circulate this notice to all users of this device so that they are aware of the product issue and associated hazard/harm.
3) Post this notice near the affected unit(s) for ease of reference.
4) Complete and return the response form to the Recalling Firm promptly and no later than 30 days from receipt via email to: ultrasound.corrections@philips.com or fax to 1-833-512-7756.
In addition, because the software defect may intermittently cause the system to lock-up when exiting Review mode, customer are asked to take the following steps to minimize the likelihood of occurrence:
1. Acquire a loop while in xPlane, xPlane Doppler, or Dual mode.
2. Do NOT adjust an imaging control (for example: Rotate, Tilt, Gain) while the loop capture is in progress.* (*If the imaging controls have been adjusted during the loop capture, Philips recommends that the system be rebooted prior to reviewing the loop in Review mode).
3. Allow the loop |
Quantity in Commerce | Total = 10,583 systems (EPIQ and Afiniti) |
Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Albania, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Brazil, Brunei Darussalam, Cambodia, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, French Guiana, Germany, Gibraltar, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Kuwait, Kyrgyzstan, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Macedonia, Malaysia, Martinique, Mauritius, Mayotte, Mexico, Moldova, Monaco, Mongolia, Montenegro, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, State of Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam, Virgin Island, Yemen and Zambia. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = IYO
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