| | Class 2 Device Recall Philips EPIQ series and Affiniti Series |  |
| Date Initiated by Firm | March 11, 2022 |
|---|
| Date Posted | November 12, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0428-2027 |
|---|
| Recall Event ID |
100162 |
| 510(K)Number | K211597 |
|---|
| Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
| Product | Philips EPIQ series and Affiniti series Diagnostic Ultrasound Systems with the Auto Measure licensed Option with Software Versions 9.0 and 9.0.1.
Model Numbers:
795117, 795118, 795190, 795200, 795201, 795204, 795205, 795208, 795210, 795218, 795231, 795232 and 795234
The intended use of EPIQ Series Diagnostic Ultrasound Systems is diagnostic ultrasound
imaging and fluid flow analysis of the human body. |
|---|
| Code Information |
Philips EPIQ series and Affiniti series Diagnostic Ultrasound Systems with the Auto Measure licensed Option with Software Versions 9.0 and 9.0.1.
Model Number / Serial Number / UDI code:
795117 US121B0844 (01)00884838097841(21)US121B0844
795118 US914D0576 (01)00884838056244(21)US914D0576
795190 US121R0746 (01)00884838097148(21)US121R0746
795190 US121R0747 (01)00884838097148(21)US121R0747
795190 US121R0748 (01)00884838097148(21)US121R0748
795190 US121R0749 (01)00884838097148(21)US121R0749
795190 US121R0750 (01)00884838097148(21)US121R0750
795190 US121R0751 (01)00884838097148(21)US121R0751
795190 US121R0752 (01)00884838097148(21)US121R0752
795190 US121R0753 (01)00884838097148(21)US121R0753
795190 US121R0754 (01)00884838097148(21)US121R0754
795190 US121R0794 (01)00884838097148(21)US121R0794
795190 US121R0795 (01)00884838097148(21)US121R0795
795190 US121R0796 (01)00884838097148(21)US121R0796
795190 US121R0797 (01)00884838097148(21)US121R0797
795190 US121R0798 (01)00884838097148(21)US121R0798
795190 US121R0799 (01)00884838097148(21)US121R0799
795190 US121R0800 (01)00884838097148(21)US121R0800
795190 US121R0801 (01)00884838097148(21)US121R0801
795190 US121R0802 (01)00884838097148(21)US121R0802
795190 US121R0803 (01)00884838097148(21)US121R0803
795190 US121R0804 (01)00884838097148(21)US121R0804
795190 US121R0897 (01)00884838097148(21)US121R0897
795190 US121R1936 (01)00884838097148(21)US121R1936
795190 US121R2004 (01)00884838097148(21)US121R2004
795190 US121R2005 (01)00884838097148(21)US121R2005
795190 US122R0287 (01)00884838106598(21)US122R0287
795190 US122R0338 (01)00884838106598(21)US122R0338
795190 US122R0339 (01)00884838106598(21)US122R0339
795190 US122R0340 (01)00884838106598(21)US122R0340
795190 US221R0237 (01)00884838097148(21)US221R0237
795190 US321R0826 (01)00884838097148(21)US321R0826
795190 US321R1074 (01)00884838097148(21)US321R1074
795190 US321R1075 (01)00884838097148(21)US321R1075
795190 US321R1076 (01)00884838097148(21)US321R1076
795190 US321R1077 (01)00884838097148(21)US321R1077
795190 US321R1078 (01)00884838097148(21)US321R1078
795190 US321R1079 (01)00884838097148(21)US321R1079
795190 US321R1782 (01)00884838097148(21)US321R1782
795190 US421R1110 (01)00884838101043(21)US421R1110
795190 US421R1111 (01)00884838101043(21)US421R1111
795190 US521R1598 (01)00884838101043(21)US521R1598
795190 US621R1651 (01)00884838101043(21)US621R1651
795190 US721R0774 (01)00884838101043(21)US721R0774
795190 US921R1236 (01)00884838106598(21)US921R1236
795190 US921R1238 (01)00884838106598(21)US921R1238
795190 US921R1304 (01)00884838106598(21)US921R1304
795190 USD20R0807 (01)00884838097148(21)USD20R0807
795190 USD21R0743 (01)00884838106598(21)USD21R0743
795190 USD21R0755 (01)00884838106598(21)USD21R0755
795190 USD21R0785 (01)00884838106598(21)USD21R0785
795190 USD21R0891 (01)00884838106598(21)USD21R0891
795190 USD21R0892 (01)00884838106598(21)USD21R0892
795190 USD21R0902 (01)00884838106598(21)USD21R0902
795190 USD21R1028 (01)00884838106598(21)USD21R1028
795190 USD21R1095 (01)00884838106598(21)USD21R1095
795190 USD21R1141 (01)00884838106598(21)0023483467
795190 USD21R1142 (01)00884838106598(21)USD21R1142
795190 USD21R1143 (01)00884838106598(21)USD21R1143
795190 USD21R1144 (01)00884838106598(21)USD21R1144
795190 USD21R1145 (01)00884838106598(21)USD21R1145
795190 USD21R1212 (01)00884838106598(21)USD21R1212
795190 USD21R1213 (01)00884838106598(21)USD21R1213
795190 USD21R1218 (01)00884838106598(21)USD21R1218
795190 USD21R1260 (01)00884838106598(21)USD21R1260
795190 USD21R1341 (01)00884838106598(21)USD21R1341
795190 USD21R1342 (01)00884838106598(21)USD21R1342
795190 USD21R1462 (01)00884838106598(21)USD21R1462
795190 USD21R1619 (01)00884838106598(21)USD21R1619
795190 USD21R1620 (01)00884838106598(21)USD21R1620
795190 USD21R1621 (01)00884838106598(21)USD21R1621
795190 USD21R1636 (01)00884838106598(21)USD21R1636
795190 USD21R1686 (01)00884838106598(21)USD21R1686
795190 USD21R1756 (01)00884838106598(21)USD21R1756
795190 USD21R1757 (01)00884838106598(21)USD21R1757
795190 USD21R1758 (01)00884838106598(21)USD21R1758
795190 USD21R1995 (01)00884838106598(21)USD21R1995
795190 USD21R1997 (01)00884838106598(21)USD21R1997
795190 USN20R1089 (01)00884838097148(21)USN20R1089
795190 USN20R1124 (01)00884838097148(21)USN20R1124
795190 USN20R1207 (01)00884838097148(21)USN20R1207
795190 USN20R1208 (01)00884838097148(21)USN20R1208
795190 USN21R0342 (01)00884838106598(21)USN21R0342
795190 USN21R0427 (01)00884838106598(21)USN21R0427
795190 USN21R0428 (01)00884838106598(21)USN21R0428
795190 USN21R0750 (01)00884838106598(21)USN21R0750
795190 USN21R1000 (01)00884838106598(21)USN21R1000
795190 USN21R1130 (01)00884838106598(21)USN21R1130
795190 USN21R1131 (01)00884838106598(21)USN21R1131
795190 USN21R1132 (01)00884838106598(21)USN21R1132
795190 USN21R1316 (01)00884838106598(21)USN21R1316
795190 USN21R1500 (01)00884838106598(21)USN21R1500
795190 USN21R1501 (01)00884838106598(21)USN21R1501
795190 USN21R1502 (01)00884838106598(21)USN21R1502
795190 USN21R1890 (01)00884838106598(21)USN21R1890
795190 USN21R2117 (01)00884838106598(21)USN21R2117
795190 USN21R2311 (01)00884838106598(21)USN21R2311
795190 USN21R2313 (01)00884838106598(21)USN21R2313
795190 USN21R2314 (01)00884838106598(21)USN21R2314
795190 USN21R2347 (01)00884838106598(21)USN21R2347
795190 USN21R2374 (01)00884838106598(21)USN21R2374
795190 USO20R0607 (01)00884838097148(21)USO20R0607
795190 USO20R0750 (01)00884838097148(21)USO20R0750
795190 USO20R0945 (01)00884838097148(21)USO20R0945
795190 USO20R0947 (01)00884838097148(21)USO20R0947
795190 USO21R0839 (01)00884838106598(21)USO21R0839
795190 USO21R1428 (01)00884838106598(21)USO21R1428
795190 USO21R1916 (01)00884838106598(21)USO21R1916
795190 US421R1750 (01)00884838101043(21)US421R1750
795190 US521R0579 (01)00884838101043(21)US521R0579
795200 US116B0313 N/A
795200 US119B0393 (01)00884838047693(21)US119B0393
795200 US119B0394 (01)00884838047693(21)US119B0394
795200 US119B0395 (01)00884838047693(21)US119B0395
795200 US119B1761 (01)00884838047693(21)US119B1761
795200 US120B1006 (01)00884838047693(21)US120B1006
795200 US120B1007 (01)00884838047693(21)US120B1007
795200 US217B0553 (01)00884838047693(21)US217B0553
795200 US218B0635 (01)00884838047693(21)US218B0635
795200 US218B0672 (01)00884838047693(21)US218B0672
795200 US316B0754 N/A
795200 US318B2117 (01)00884838047693(21)US318B2117
795200 US415B0243 N/A
795200 US418B0771 (01)00884838047693(21)US418B0771
795200 US419B1140 (01)00884838047693(21)US419B1140
795200 US516B1078 (01)00884838047693(21)US516B1078
795200 US518B0421 (01)00884838047693(21)US518B0421
795200 US615B0509 N/A
795200 US615B0964 N/A
795200 US616B0358 (01)00884838047693(21)US616B0358
795200 US616B0835 (01)00884838047693(21)US616B0835
795200 US713B0277 N/A
795200 US713B0326 N/A
795200 US713B0589 N/A
795200 US717B0403 (01)00884838047693(21)US717B0403
795200 US717B0404 (01)00884838047693(21)US717B0404
795200 US719B0099 (01)00884838047693(21)US719B0099
795200 US813B0122 N/A
795200 US815B0215 N/A
795200 US815B1006 N/A
795200 US914B0492 N/A
795200 US918B0046 (01)00884838047693(21)US918B0046
795200 USD13B0634 N/A
795200 USD15B0953 N/A
795200 USN15B0118 N/A
795200 USN15B0889 N/A
795200 USN17B1631 (01)00884838047693(21)USN17B1631
795200 USO13B0642 N/A
795200 USO14B0525 N/A
795200 USO17B0990 (01)00884838047693(21)USO17B0990
795200 USO17B1142 (01)00884838047693(21)USO17B1142
795200 USO19B2573 (01)00884838047693(21)USO19B2573
795200 USO15B0924 N/A
795200 US114B0128 N/A
795201 US116B0770 N/A
795201 US116B0771 N/A
795201 US116B0986 N/A
795201 US116B1083 N/A
795201 US116B1084 N/A
795201 US117B0790 (01)00884838047693(21)0023145837
795201 US117B0796 (01)00884838047693(21)US117B0796
795201 US214B0094 N/A
795201 US215B0613 N/A
795201 US216B0167 N/A
795201 US217B0324 (01)00884838047693(21)US217B0324
795201 US217B0325 (01)00884838047693(21)US217B0325
795201 US219B0295 (01)00884838047693(21)US219B0295
795201 US219B0296 (01)00884838047693(21)US219B0296
795201 US314B0062 N/A
795201 US316B1078 N/A
795201 US317B0859 (01)00884838047693(21)US317B0859
795201 US317B0860 (01)00884838047693(21)US317B0860
795201 US318B1971 (01)00884838047693(21)US318B1971
795201 US318B1997 (01)00884838047693(21)US318B1997
795201 US318B1998 (01)00884838047693(21)US318B1998
795201 US318B2215 (01)00884838047693(21)US318B2215
795201 US318B2216 (01)00884838047693(21)US318B2216
795201 US319B0862 (01)00884838047693(21)US319B0862
795201 US319B0863 (01)00884838047693(21)US319B0863
795201 US414B0063 N/A
795201 US414B0147 N/A
795201 US417B0009 (01)00884838047693(21)US417B0009
795201 US417B0100 (01)00884838047693(21)US417B0100
795201 US418B0682 (01)00884838047693(21)US418B0682
795201 US418B0711 (01)00884838047693(21)US418B0711
795201 US418B0775 (01)00884838047693(21)US418B0775
795201 US418B0776 (01)00884838047693(21)US418B0776
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795201 US418B0997 (01)00884838047693(21)US418B0997
795201 US418B1485 (01)00884838047693(21)US418B1485
795201 US514B0487 N/A
795201 US515B0870 N/A
795201 US516B1010 (01)00884838047693(21)US516B1010
795201 US517B1565 (01)00884838047693(21)US517B1565
795201 US518B0277 (01)00884838047693(21)US518B0277
795201 US518B1134 (01)00884838047693(21)US518B1134
795201 US615B1161 N/A
795201 US616B0362 (01)00884838047693(21)US616B0362
795201 US616B0455 (01)00884838047693(21)US616B0455
795201 US617B1137 (01)00884838047693(21)US617B1137
795201 US617B1138 (01)00884838047693(21)US617B1138
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795201 US617B1140 (01)00884838047693(21)US617B1140
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795201 US617B1142 (01)00884838047693(21)US617B1142
795201 US618B0127 (01)00884838047693(21)US618B0127
795201 US618B0128 (01)00884838047693(21)US618B0128
795201 US618B0206 (01)00884838047693(21)US618B0206
795201 US618B0311 (01)00884838047693(21)US618B0311
795201 US618B0312 (01)00884838047693(21)US618B0312
795201 US618B0494 (01)00884838047693(21)US618B0494
795201 US618B0897 (01)00884838047693(21)US618B0897
795201 US618B0954 (01)00884838047693(21)US618B0954
795201 US618B0956 (01)00884838047693(21)US618B0956
795201 US618B1004 (01)00884838047693(21)US618B1004
795201 US714B0126 N/A
795201 US715B1158 N/A
795201 US716B0093 (01)00884838047693(21)US716B0093
795201 US716B0853 (01)00884838047693(21)US716B0853
795201 US718B1062 (01)00884838047693(21)US718B1062
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795201 US721B0693 (01)00884838097872(21)US721B0693
795201 US814B0303 N/A
795201 US815B1009 N/A
795201 US815B1174 N/A
795201 US816B0451 (01)00884838047693(21)US816B0451
795201 US816B0500 (01)00884838047693(21)US816B0500
795201 US816B0598 (01)00884838047693(21)US816B0598
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795201 US818B1637 (01)00884838047693(21)US818B1637
795201 US913B0441 N/A
795201 US914B0535 N/A
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795201 US915B0651 N/A
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795201 USD14B0104 N/A
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795201 USD14B0655 N/A
795201 USD14B0656 N/A
795201 USD14B0657 N/A
795201 USD14B0963 N/A
795201 USD15B0209 N/A
795201 USD15B0582 N/A
795201 USD16B0386 (01)00884838047693(21)USD16B0386
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795201 USN14B0932 N/A
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795201 USN18B1449 (01)00884838047693(21)USN18B1449
795201 USO14B0200 N/A
795201 USO14B0561 N/A
795201 USO14B0919 N/A
795201 USO15B0369 N/A
795201 USO15B1131 N/A
795201 USO16B0678 (01)00884838047693(21)USO16B0678
795201 USO17B1552 (01)00884838047693(21)USO17B1552
795201 USO17B1553 (01)00884838047693(21)USO17B1553
795204 US314C0613 N/A
795204 US316C0533 N/A
795204 US316C0534 N/A
795204 US318C1691 (01)00884838047686(21)US318C1691
795204 US318C1692 (01)00884838047686(21)US318C1692
795204 US416C0796 N/A
795204 US516C0435 (01)00884838047686(21)US516C0435
795204 US615C1152 N/A
795204 US619C0699 (01)00884838047686(21)US619C0699
795204 US714C0736 N/A
795204 US818C1253 (01)00884838047686(21)US818C1253
795204 US819C0122 (01)00884838047686(21)US819C0122
795204 US915C0060 N/A
795204 US915C0919 N/A
795204 US915C1130 N/A
795204 US917C0089 (01)00884838047686(21)US917C0089
795204 US918C1962 (01)00884838047686(21)US918C1962
795204 USD14C0167 N/A
795204 USD15C0944 N/A
795204 USD18C0061 (01)00884838047686(21)USD18C0061
795204 USD19C0436 (01)00884838047686(21)USD19C0436
795204 USD19C0437 (01)00884838047686(21)USD19C0437
795204 USD19C0480 (01)00884838047686(21)USD19C0480
795204 USN15C0641 N/A
795204 USN16C0227 (01)00884838047686(21)USN16C0227
795204 USO15C0651 N/A
795204 USO15C1178 N/A
795204 USO16C0662 (01)00884838047686(21)USO16C0662
795204 USO16C0663 (01)00884838047686(21)USO16C0663
795204 USO17C1140 (01)00884838047686(21)USO17C1140
795204 USO18C0874 (01)00884838047686(21)USO18C0874
795205 US114C0308 N/A
795205 US816C1004 (01)00884838047686(21)US816C1004
795205 US816C1005 (01)00884838047686(21)US816C1005
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795234 USO20B1628 (01)00884838102514(21)USO20B1628 |
| FEI Number |
3019216
|
Recalling Firm/
Manufacturer |
Philips Ultrasound, LLC
22100 Bothell Everett Hwy
Bothell
WA
98021-8431
|
| For Additional Information Contact | Philips Customer Care Solutions Center
800-722-9377 |
|---|
Manufacturer Reason
for Recall | Due to software issues that may display incorrect values in the results box, final report, or both, potentially leading to the need for re-measureemtn of values. |
|---|
FDA Determined
Cause 2 | Software design |
|---|
| Action | On 03/15/2022, an "IMPORTANT PRODUCT NOTICE" was sent via certified mail to customers informing them that Philips has identified software issues associated with the Auto Measure feature. These issues may lead to the display of incorrect values in the Auto Measure results box, final report, or both, potentially leading to the need for re-measurement of values. These issues are specific to user workflows associated with the manual edit or manual trace option.
Customers were instructed to:
The actions that a customer can take to minimize the effect of the problem
(1) There are two options. You can disable the Auto Measure feature as described in Option A below, or you may continue to use the Auto
Measure per the conditions described in Option B below.
Option A - how to disable the Auto Measure feature:
a. Power up the system and allow it to complete the boot sequence
b. Touch Utilities.
c. On the System tab, touch Setups.
d. Select the Analysis button on the left of the setups screen
e. Select the Adult Echo tab at the top of the setups screen
f. In the Tools and Results tab, uncheck both the Doppler and 2D items in the
Auto Measure box.
Option B - To continue to use the Auto Measure feature and accept the automated measurements, the software issues will not be observed.
The issues are triggered when editing the Auto Measure values. Therefore, if there is a
need to edit the measurements taken using the Auto Measure feature, you will need to
perform the measurements manually by following the steps below:
a. Rotate the Auto Measure control on the bottom right of the Measure Tab to
ff).
b. Manually perform the desired measurement.
A Philips Field Service Engineer will contact you to schedule a software update to resolve the issue (reference FCO79500558).
For questions or concerns - contact your local
Philips representative: 1-800-722-9377 and reference FCO79500558. |
|---|
| Quantity in Commerce | 995 systems |
|---|
| Distribution | U.S.: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
O.U.S.: Argentina, Australia, Austria, Belgium, Colombia, Croatia, Denmark, Finland, France, Germany, Hong Kong, India, Italy, Martinique, Monaco, Netherlands, New Zealand, Nicaragua, Poland, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom. |
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
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.
|
| 510(K) Database | 510(K)s with Product Code = IYN
|
|---|
|
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