GE Medical Systems recalls Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography machines due to a missing or incorrect X-Ray Warning label, a nonconformance with FDA regulations.
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).
GE Medical Systems is recalling Senographe Pristina, Pristina Serena, and Pristina Serena 3D mammography machines because some units have a missing or incorrect X-Ray Warning label. This label issue is a nonconformance with FDA regulations and could lead to improper radiation safety.
The missing or incorrect X-Ray Warning label does not pose a direct risk of injury during normal use. However, it is a nonconformance with FDA regulations that could lead to improper radiation safety if the label is not present or correct.
Women who use these mammography machines for screening or diagnostic purposes may be affected. Healthcare providers using the machines are at the highest risk due to the regulatory nonconformance.
Check for the product names: Senographe Pristina, Pristina Serena, or Pristina Serena 3D. The GTINs listed in the recall notice can help identify affected units.
Look for the X-Ray Warning label on the machine; if missing or incorrect, the unit is affected.
The recall is due to some units having a missing or incorrect X-Ray Warning label, which is a nonconformance with FDA regulations.
Check if your machine is listed as Senographe Pristina, Pristina Serena, or Pristina Serena 3D with the provided GTINs.
No, the recall does not require immediate stoppage; the hazard is a regulatory nonconformance that does not pose a direct risk of injury during normal use.
We’ve drafted a message you can send GE Medical Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-0875-2026 — GE Medical Systems GE Medical Systems Hello, I own a GE Medical Systems that is covered by recall Z-0875-2026 from GE Medical Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
