GE HealthCare recalls OEC 9900 Elite C-arm systems with missing lead tape, increasing radiation exposure risk. Affected units may require repair or replacement.
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
GE HealthCare is recalling certain OEC 9900 Elite C-arm systems that have missing lead tape in collimator covers. This increases radiation exposure to patients and operators without user detection.
The collimator covers lack a full layer of lead tape, which normally shields against radiation. This small gap increases radiation exposure without the user noticing the missing protection.
Medical professionals using these systems for imaging are most at risk. Patients and operators during procedures may experience higher radiation exposure.
Check for GE HealthCare OEC 9900 Elite C-arm systems with GTIN 00840682114349. The missing lead tape is not detectable by the user.
Inspect collimator covers for missing lead tape, though this is not detectable by the user.
GE HealthCare found that certain OEC 9900 Elite C-arm systems have missing lead tape in collimator covers, increasing radiation exposure risk.
The affected systems have GTIN 00840682114349 and missing lead tape in collimator covers, which is not detectable by the user.
The recall record does not specify a remedy, so contact GE HealthCare for guidance.
We’ve drafted a message you can send GE HealthCare to request your refund or repair — edit it as you like.
Subject: Recall Z-2342-2025 — GE HealthCare GE HealthCare Hello, I own a GE HealthCare that is covered by recall Z-2342-2025 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
