—#215633

Product

GE HealthCare OEC 9800.

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K021049, K111551, K132027
Affected lot / code info: GTIN: 00840682114349

Why it was recalled

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.

Root cause (FDA determination)

Radiation Control for Health and Safety Act

Action the firm took

GE HealthCare will send a customer letter providing safety instructions as an immediate mitigation, to communicate the risk of additional radiation and that the equipment should only be used by personnel properly trained and authorized in the use of ionizing radiation. A user should observe proper safety practices during equipment operation as required by the operator manual. GE HealthCare will correct all affected OEC 9800 and OEC 9900 Elite systems (28 units) by visually inspecting for the presence of lead shield tape on the collimator cover and replacing the collimator cover if it is found non-compliant, at no cost to the customer.

Recalling firm

Firm: GE Medical Systems, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2025-07-02
Posted by FDA: 2025-08-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #215633. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.