Reported Feb 14, 2024 · Ongoing
Senographe Pristina
GE Medical Systems, SCS
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: GE Medical Systems, SCS · 283 rue de la Miniere · Buc · N/A
Is this the product you have?
- Senographe Pristina
- Lot codes and dates
- GTIN(s)
195278022745195278276971195278628916195278661999195278665379840682118460840682142052840682145879
- GTIN(s)
- Amount recalled
- 180 units (60 US; 120 OUS)
Where it was sold
- Nationwide
Why it was recalled
X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements.
This product could cause temporary or reversible health problems — stop using it.
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