Reported Nov 15, 2023 · Completed
Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
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 Affiniti 70Diagnostic Ultrasound System Model # 795210
- Lot codes and dates
- Following serial numbers operating with software version 10.0
- Model 795210/UDI(01)00884838106611/Serial
- NumbersUS523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292
- Amount recalled
- 7 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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