GE Healthcare recalls Optima XR200amx mobile X-ray systems with specific model numbers due to potential column safety mechanism failure if bolts are missing after column replacement.
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
GE Healthcare is recalling certain Optima XR200amx mobile X-ray systems that had column replacements. If bolts in the Column Safety mechanism are missing, the X-ray arm could drop unexpectedly, causing injury.
After a column replacement, some bolts in the Column Safety mechanism may be missing. If the internal counterpoise cable fails, the X-ray arm can drop suddenly, potentially causing injury.
Healthcare facilities using the recalled Optima XR200amx mobile X-ray systems with model numbers 5555000-3, 5555000-4, or A0659MB are most at risk. Users must check if their system has had a column replacement.
Check for model numbers 5555000-3, 5555000-4, or A0659MB on the system. The recall includes specific serial numbers listed in the official notice.
Verify if your system has had a column replacement since the recall was issued.
Reach out to GE Healthcare for guidance on whether your system needs repair or replacement.
GE Healthcare has found that some bolts in the Column Safety mechanism can be missing after column replacements, which could cause the X-ray arm to drop unexpectedly.
Model numbers 5555000-3, 5555000-4, and A0659MB are affected, with specific serial numbers listed in the recall notice.
No, but you should check if your system has had a column replacement and contact GE Healthcare for further instructions.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-0811-2025 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-0811-2025 from GE Healthcare. 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.
