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)
    • 195278022745
    • 195278276971
    • 195278628916
    • 195278661999
    • 195278665379
    • 840682118460
    • 840682142052
    • 840682145879
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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.