Lower riskMedical device recall · FDA · Published July 2, 2025
GE HealthCare OEC 9900 Elite C-arm Systems Recall: Radiation Exposure Risk
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.
Take action
Contact the company
📍Recalling firmGE Medical Systems, LLC3000 N Grandview Blvd · Waukesha, WI 53188-1615
“GE HealthCare OEC 9900 Elite C-arm Systems Recall: Radiation Exposure Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51915-ge-healthcare-oec-9900-elite-c-arm-systems-recall-radiation. Based on FDA recall #Z-2342-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2342-2025%22&limit=1).
The FDA announced on July 2, 2025, that GE Medical Systems, LLC is recalling GE HealthCare OEC 9900 Elite C-arm Systems due to a radiation exposure hazard. The company said the units are missing lead tape in collimator covers, increasing radiation risk to patients and operators.
How to tell if you have it
GE HealthCare OEC 9900 Elite C-arm Systems
UPC: 00840682114349
The hazard
The recalled systems lack the full layer of lead tape in their collimator covers, leading to a small increase in radiation exposure to the patient and/or operator. The FDA said this missing component is not detectable by the user.
Context
GovInfoNow's records show GE Medical Systems, LLC has 27 other recalls on record since March 30, 2018. Recent brand recalls include a column safety failure risk for the Optima XR240amx Mobile X-Ray System (June 5, 2026) and an electrical shock risk for the Allia IGS 3 Pulse X-Ray System (April 20, 2026). Other recent recalls of similar products include the Philips Brilliance CT 64 Medical Scanner Recall (August 7, 2026), the GE Maxxus Nuclear Medicine Systems Recall (December 10, 2025), and the Elekta Leksell GammaPlan 11.1 Software Recall (December 12, 2025).
How to tell if you have this one
Check for GE HealthCare OEC 9900 Elite C-arm systems with GTIN 00840682114349. The missing lead tape is not detectable by the user.
Brand
GE HealthCare
Product
GE HealthCare OEC 9900 Elite C-arm Systems
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.
Recall number
Product, codes & lots
Quantity
Z-2341-2025
GE HealthCare OEC 9800.; GTIN: 00840682114349
—
Z-2342-2025
GE HealthCare OEC 9900 Elite C-arm Systems.; GTIN: 00840682114349
—
Based on the official FDA remedy
What to do — step by step
Check for Missing Lead Tape
Inspect collimator covers for missing lead tape, though this is not detectable by the user.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-2342-2025 (July 2, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2342-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 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.