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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

Philips Ultrasound, Inc.: EPIQ and Affiniti Ultrasound Systems Recalled for Delayed Imaging Software

Agency Publication Date: November 9, 2023
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Summary

Philips Ultrasound, Inc. is recalling 90 diagnostic ultrasound systems, including EPIQ 5, 7, CVx, Elite, and Affiniti 70 models, that are operating with software version 10.0. These specific devices may display a delayed image rather than a real-time image during medical examinations. This defect can lead to incorrect diagnoses or complications during guided medical procedures. Consumers should contact their healthcare provider or the manufacturer to determine if their system is affected and to receive the necessary software correction.

Risk

The software defect causes the ultrasound to present a delayed image instead of a real-time view. This lag can lead to medical errors, such as a clinician misplacing a needle or instrument during a procedure or misinterpreting dynamic anatomical movements, potentially resulting in patient injury.

What You Should Do

  1. Identify if your facility uses Philips EPIQ (models 7G, 7C, 7W, 5G, 5W, CVx, Elite) or Affiniti 70 diagnostic ultrasound systems.
  2. Check the software version on your system to see if it is running version 10.0.
  3. Verify your specific model and serial number against the affected list. For EPIQ models, affected serial numbers include US818B1520, USN16B0579, USD16B1124, US220C0963, and others. For Affiniti 70, check for serial numbers US523F1930, US918F1158, US918F1159, US723F1377, US523F1496, US523F1497, and US217F0292.
  4. If your system is running software version 10.0, contact your healthcare provider or Philips Ultrasound, Inc. for technical support and instructions on how to receive the software update.
  5. If you have additional questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Software correction or technical instructions

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Philips EPIQ 7G Diagnostic Ultrasound System
Model / REF:
795200
UPC Codes:
00884838047693
Lot Numbers:
US818B1520
US115B0264
USD14B0996
USN18B0465
US915B0649
US516B0839
US516B0840
US516B0841
US617B1185
US617B1186
US617B1187
US318B2182
USN19B1084
USD13B0543
US419B1858
US419B1860
US419B1949
Product: Philips EPIQ 7C Diagnostic Ultrasound System
Model / REF:
795201
UPC Codes:
00884838047693
Lot Numbers:
USN16B0579
Product: Philips EPIQ 7W Diagnostic Ultrasound System
Model / REF:
795202
UPC Codes:
00884838047693
Lot Numbers:
US416B1186
US813B0429
US813B0430
US813B0432
USD16B1124
USD16B1126
USD16B1129
US419B1141
US419B1142
US419B1143
US419B1289
USO18B1195
Product: Philips EPIQ 5G Diagnostic Ultrasound System
Model / REF:
795204
UPC Codes:
00884838047686
Lot Numbers:
US220C0963
US818C1422
US818C1432
US818C1433
US818C1434
US719C0684
Product: Philips EPIQ 5W Diagnostic Ultrasound System
Model / REF:
795206
UPC Codes:
00884838047686
Lot Numbers:
USD16C1116
USD17C0754
USD18C0039
USO15C0951
US320C0864
Product: Philips EPIQ CVx Diagnostic Ultrasound System
Model / REF:
795231
UPC Codes:
00884838114135
Lot Numbers:
US723B1124
US120B0345
US120B0348
US120B1131
US723B1125
US723B1121
US723B1122
US723B1123
Product: Philips EPIQ Elite Diagnostic Ultrasound System
Model / REF:
795234
UPC Codes:
00884838107540
Lot Numbers:
USO22B0941
US322B0678
US322B0676
US723B1023
US723B1126
US723B1024
US723B1022
US723B1128
US723B1127
US423B1238
US723B1021
US521B1455
US723B1017
US323B2026
US723B1018
US723B1019
US223B1718
US223B1719
US223B1720
USD22B0063
US323B0675
US723B1020
US523B0298
US523B0299
US523B0300
US523B2699
US523B2700
US523B2701
US523B2702
US523B2703
US523B2704
US523B2705
US523B2873
US523B2872
Product: Philips Affiniti 70 Diagnostic Ultrasound System
Model / REF:
795210
UPC Codes:
00884838106611
Lot Numbers:
US523F1930
US918F1158
US918F1159
US723F1377
US523F1496
US523F1497
US217F0292

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93218
Status: Resolved
Manufacturer: Philips Ultrasound, Inc.
Sold By: Authorized Philips medical equipment distributors
Manufactured In: United States
Units Affected: 2 products (83 systems; 7 systems)
Distributed To: Arizona, California, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Maryland, Montana, Nebraska, Nevada, Ohio, Tennessee, Texas, Utah, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.