Quick Facts at a Glance
- Recall Date
- October 24, 2025
- Hazard Level
- HIGH
- Brand
- GE Medical Systems
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- GE Medical Systems
- Product type
- Mammography System
- Model numbers
- GTINs: 00840682118460, 00840682142052, 00840682145879, 00195278022745, 00195278276971, 00195278661999, 00195278665379, 00195278914026
- Sold at
- Multiple Retailers
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 24, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GE Medical Systems, LLC or your healthcare provider for instructions. Notification method: N/A
About This Product
The Senographe Pristina system is used for screening and diagnostic mammography, essential for early detection of breast cancer. Healthcare providers rely on its proper function for accurate patient assessments.
Why This Is Dangerous
The missing or incorrect X-Ray Warning labels increase the risk of improper use, which can lead to dangerous exposure to radiation. This nonconformance to FDA regulations compromises patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face delays in screening services and potential health risks if the devices are used without proper labeling.
Practical Guidance
How to identify if yours is affected
- Check the model number against the list of affected GTINs.
- Examine the device for any warning labels present.
- Contact your healthcare provider for verification.
Where to find product info
Model numbers and GTINs can typically be found on the device’s identification label or user manual.
What timeline to expect
Expect a realistic timeline of 4-8 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Contact GE Medical Systems directly for assistance.
- Document all communications in case further action is needed.
How to prevent similar issues
- Always verify that medical devices have all necessary safety labels before use.
- Check for current recalls on devices regularly.
- Ensure devices are compliant with FDA regulations.
Documentation advice
Keep copies of receipts, correspondence with the manufacturer, and any other relevant documentation regarding the recall.
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Product Details
The recall involves Senographe Pristina, Pristina Serena, and Pristina Serena 3D systems. A total of 1,818 units are affected, including 1,580 in the U.S. These systems were distributed in the U.S. and other countries.
Key Facts
- Recall date: October 24, 2025
- Total quantity recalled: 1,818
- FDA classification: Class II
- Affected models include multiple GTINs
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Safety Guide
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