|
Class 2 Device Recall ACUSON Juniper Diagnostic Ultrasound System |
|
Date Initiated by Firm |
February 23, 2024 |
Date Posted |
April 19, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1599-2024 |
Recall Event ID |
94211 |
510(K)Number |
K201130
|
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
Product |
ACUSON Juniper Diagnostic Ultrasound System, REF: 11335791, and ACUSON Juniper Select Diagnostic Ultrasound System, REF: 11653093, running software version VA10x with DICOM SR Cardiac option, from VB10A to VB10G, VB11A, VB11B, VB30B and VB30C |
Code Information |
REF/UDI-DI: 11335791/04056869152059, and 11653093/04056869957357.
Serial Numbers:
571063
556506
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555518
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556412
556247
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556341
556010
555614
555043
555517
555525
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555531
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555354
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555380
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555252
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553355
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553078
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551935
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552200
550741
552036
550793
550796
550789
550810
550703
550704
550705
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550500
550032
550779
550628
550450
552670
570292
573061
557176
571037
556444
555478
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553041
555361
555103
553483
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551783
551525
550848
551647
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551108
550783
550785
556688
555885
556694
555878
556687
555887
555638
555112
556256
556360
556255
555324
555031
555863
555945
555527
555104
555025
555630
555567
555439
555410
555259
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553036
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552912
553776
553663
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553388
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551947
552959
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552824
551851
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552020
551526
551949
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551901
551727
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551629
551611
551014
551017
551018
550777
550650
550473
550446
570038
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557024
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557027
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555501
556268
555845
555846
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553684
555499
556946
555500
555463
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555462
555457
555441
555442
555426
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555325
552803
550584
550094
575055
573189
573427
570060
557334
556878
556362
555974
555882
555973
555850
555576
555578
555655
555526
555009
555427
555054
555428
555585
555034
555657
555573
553479
552908
550994
551943
551889
551914
550031
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550087
550845
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551971
557335
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575073
576277
576278
578054
571070
570265
555130
555420
553603
553583
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553586
553587
555292
555293
553610
553611
552887
552037
552038
550663
571512
573426
571539
570024
573387
570025
570220
570224
573029
573030
570242
556165
570399
570402
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570250
570221
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575048
570228
557338
557286
556993
557287
557179
556594
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556799
557028
557054
556790
557020
556166
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556750
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556595
556604
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556698
556411
556325
555081
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556212
555858
555859
555483
555515
555028
555557
555520
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555029
555496
555007
555620
555624
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555467
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555399
555398
555349
553526
555351
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553490
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553054
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550295
551886
550847
550600
550293
550983
550291
550978
550985
550575
573423
572044
557371
551672
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550885
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570495
575117
570500
573292
570517
557290
570454
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575098
570431
570484
573150
575099
575123
570505
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575066
570325
570328
557105
570506
570508
570433
556792
570331
575062
570321
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575065
557268
570100
570101
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570226
550089
557166
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557167
556942
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556903
556821
553768
555866
556024
556583
555791
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556533
556442
555865
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555801
555743
555742
555802
555804
555645
555640
555392
555036
553857
553290
552765
553293
553267
553266
552162
553268
553285
553286
553244
553291
553294
553304
551885
552159
552167
552168
553099
552164
552163
552166
552885
552169
552170
552029
552031
551571
551896
552161
552027
552028
552032
552158
551560
551908
551786
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551822
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551557
551100
551536
550730
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550912
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550436
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550322
553765
557301
557302
570427
570527
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573308
578028
578051
578052
556653
556655
556889
556654
556413
556414
556400
556415
553322
553546
553321
571046
550350
550106
550605
551707
553160
900324
900325
900323
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900322
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900321
555044
555046
553601
900336
555874
556049
556311
556546
556593
556771
556770
556818
556817
556876
575001
900415
900413
900414
575002
557052
557075
557079
557103
557136
557151
557146
557135
557250
557260
557258
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570016
557262
557275
570022
570039
557337
570044
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570099
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570190
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571010
571009
576003
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570232
557226
570239
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557433
570316
570319
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571012
570334
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571061
576208
571516
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573028
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573013
572004
573048
576237
573053
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570499
570457
570445
570518
570453
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570425
570533
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570496
570426
573055
573058
572009
572010
576013
573071
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573079
573096
573113
572019
573111
578014
572020
570480
570430
578017
570531
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573138
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573159
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578035
578034
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573212
578040
573207
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573209
610053
573216
570429
570428
573222
573231
573232
573233
573244
573255
573238
573242
573239
573247
573243
573240
573248
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573264
573256
573245
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573275
573260
573262
573263
570482
570455
570442
573281
573286
573285
573301
570526
570524
610062
610064
610065
610066
610067
573306
573312
573309
573317
573319
573318
573332
573333
573345
573344
573353
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573369
573365
578064
573368
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573376
572037
578076
576271
576270
578073
578080
578086
578087
576273
578081
576274
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576276
573397
578084
573400
573398
578085
573408
573399
573386
573410
573413
573417
573424
573428
572041
572042
578098
573437
573440
572040
610071
610072
610073
610074
610075
610076
610077
610078
610079
610080
610083
610084
610085
573478
570473
610094
571250.
|
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 22010 Se 51st St Issaquah WA 98029-7298
|
For Additional Information Contact |
425-392-9180
|
Manufacturer Reason for Recall |
On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.
|
FDA Determined Cause 2 |
Software design |
Action |
On 2/23/24, correction notices were sent to customers informing them of the following:
This issue is specific to and limited to the use of the Cardiac DICOM SR feature:
- When a user uses and configures the Cardiac DICOM SR feature to display either the MINIMUM (Min) or the MAXIMUM (Max) measured value, AND
- Makes multiple measurements of the cardiac region during an examination, AND
- Exports the results into the Cardiac DICOM SR feature, THEN
- The Cardiac DICOM SR viewer will NOT display the MINIMUM (Min) or MAXIMUM (Max) value and will instead display the LAST measured value. In that case, the displayed measurement in the Cardiac DICOM SR viewer may NOT be the Minimum (Min) or MAXIMUM (Max) value measured during the examination.
To avoid potential misdiagnosis by an over- or underrepresented measured value, it is recommended to refer to the measurement values displayed on the Ultrasound System Final Report when the configuration is to display the Min or Max value.
Firm recommends a review of previous cardiac ultrasound examination results where the clinical assessment was reviewed using a DICOM SR viewer.
Your Customer Service Engineer from will contact you to schedule a facility visit to update the system or inform you of a remote update when the software update is available. The software update is currently under development and estimated to be available by spring/summer of 2024.
Please ensure that all users of the affected devices within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein.
If you have further questions, please contact the firm's Ultrasound Service Customer Care Center at 1-800-888-7436.
Not Affected:
-ACUSON Juniper Ultrasound System, product version 2.5, software version VB30D.
- ACUSON Redwood system, product version 2.0.
|
Quantity in Commerce |
5090 |
Distribution |
Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, CR, AF, BE, AE, AZ, AO, KR, RO, HU, HR, DK, AU, DZ, CY, PL, BO, AL, NL, CI, BR, CZ, DE, AT, ES, CO, BD, CH, IT, CA, CM, DO, EC, EG, ER, ET, FI, FO, GB, GE, GR, GT, GY, HK, HN, ID, IE, IL, IN, IQ, IR, JO, JP, KE, KW, KZ, LB, LT, LU, LV, LY, MA, MD, ME, MK, MM, MN, MU, MW, MX, MY, NG, NO, NP, NZ, OM, PA, PE, PG, PK, PT, PY, QA, RS, RU, SA, SE, SG, SI, SM, SN, SV, SZ, TH, TN, TT, TW, TZ, UA, UG, UY, UZ, VN, XK, YE, ZA, ZM, ZW.
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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 and Original Applicant = Siemens Medical Solutions USA, Inc.
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