United StatesSenographe Pristina, Pristina Serena, and Pristina Serena 3D mammography systems (for screening and diagnostic mammography) are affected; they can be identified by the listed GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026. The recall was issued because some systems have a missing or incorrect X‑Ray Warning label, which is a nonconformance to FDA regulation 21 CFR 1020.30(j).
What's being recalled
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
Recalling firm: GE Medical Systems, LLC, Waukesha, WI, United States.
How to identify it
GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
The hazard
Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR ¿1020.30(j).
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S. and OUS.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada