Reported Nov 15, 2023 · Completed
Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model #…
Philips Ultrasound, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Ultrasound, Inc. · 22100 Bothell Everett Hwy · Bothell, WA · 98021-8431
Is this the product you have?
- Philips EPIQ
- Diagnostic Ultrasound System Models
EPIQ 7G(model # 795200)EPIQ 7C (Model # 795201)EPIQ 7W (Model # 795202)EPIQ 5G (model # 795204)EPIQ 5W (model # 795206)EPIQ CVx (Model # 795231)EPIQ Elite (model # 795234)
- Lot codes and dates
6 of 6 products
Products covered by this recall Model / number Barcodes Product as published 795200/UDI00884838047693Following model numbers and serial numbers operating with software version 10.0: :(01)00884838047693/Serial numbers: US818B1520 US115B0264 USD14B0996 USN18B0465 US915B0649 US516B0839 US516B0840 US516B0841 US617B1185 US617B1186 US617B1187 US318B2182 USN19B1084 USD13B0543 US419B1858 US419B1860 US419B1949 795201/UDI00884838047693(01)00884838047693/Serial Number: USN16B0579 795202/UDI00884838047693(01)00884838047693/ Serial Numbers: US416B1186 US813B0429 US813B0430 US813B0432 USD16B1124 USD16B1126 USD16B1129 US419B1141 US419B1142 US419B1143 US419B1289 USO18B1195 795204/00884838047686UDI: (01)00884838047686/ Serial Numbers: US220C0963 US818C1422 US818C1432 US818C1433 US818C1434 US719C0684 795231/0088483804768600884838114135model # 795206/ UDI: (01)00884838047686/ Serial Numbers: USD16C1116 USD17C0754 USD18C0039 USO15C0951 US320C0864 UDI: (01)00884838114135/ Serial numbers: US723B1124 US120B0345 US120B0348 US120B1131 US723B1125 US723B1121 US723B1122 US723B1123 795234/UDI00884838107540(01)00884838107540/ Serial 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 - Amount recalled
- 83 systems
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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