GE HealthCare recalls OEC 9800 C-arm systems with missing lead tape, increasing radiation exposure. Affected units may not be detectable by users. Contact GE for details.
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 OEC 9800 C-arm systems that have missing lead tape in collimator covers. This small radiation increase could affect patients or operators during medical procedures.
The collimator covers lack a full layer of lead tape, which normally blocks radiation. This missing protection causes a small increase in radiation exposure during medical imaging. The issue isn't detectable by users, so they might not notice the problem.
Medical professionals using OEC 9800 C-arm systems for imaging procedures are most at risk. Patients receiving scans with these systems may also be affected.
Check for GE HealthCare OEC 9800 models with GTIN 00840682114349. The missing lead tape isn't visible to users, so you can't tell if your unit is affected by appearance alone.
Reach out to GE HealthCare directly to confirm if your unit is affected and get instructions.
The recall involves a small increase in radiation exposure, but it's not detectable by users. GE HealthCare considers this a low-risk issue.
The missing lead tape isn't visible to users, so you can't tell by appearance alone. Check the GTIN number on your unit: 00840682114349.
No, but you should contact GE HealthCare to confirm if your unit is affected and get 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-2341-2025 — GE HealthCare GE HealthCare Hello, I own a GE HealthCare that is covered by recall Z-2341-2025 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.
