GE Medical Systems Senographe Pristina Mammography Machines: Missing X-Ray Warning Label
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.
Lower-risk recall
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).
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/51013-ge-medical-systems-senographe-pristina-mammography-machines-missing-x-ray.
Source Summary by GovInfoNow · govinfonow.com/recall/51013-ge-medical-systems-senographe-pristina-mammography-machines-missing-x-ray · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0875-2026
Cite this page
“GE Medical Systems Senographe Pristina Mammography Machines: Missing X-Ray Warning Label.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51013-ge-medical-systems-senographe-pristina-mammography-machines-missing-x-ray. Based on FDA recall #Z-0875-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0875-2026%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
GE Medical Systems- Category
Medical device
What to do — step by step
Check for X-Ray Warning Label
Look for the X-Ray Warning label on the machine; if missing or incorrect, the unit is affected.
How this recall unfolded
Recall timeline
FDA published this recall 54 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0875-2026 (October 24, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0875-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.