GE Healthcare Recalls OEC 9800 and 9900 C-Arms for Dose Display Issues
GE Healthcare is recalling 221 OEC 9800 and 9900 C-Arms because field service engineers changed the dose display to DAP, violating FDA regulations requiring AKR/CAK.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a regulatory compliance issue regarding display settings rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity recall involving labeling or configuration errors.
Plain-English summary
GE Healthcare is recalling 221 units of the OEC 9800 and OEC 9900 Elite fluoroscopic mobile C-Arms. These devices are used to provide fluoroscopic and spot-film images during diagnostic, surgical, and interventional procedures, including cardiac, orthopedic, and emergency room applications.
The recall was initiated because some users requested that Field Service Engineers (FSEs) change the dose value on the live update screen from Air Kerma Rate (AKR) / Cumulative Air Kerma (CAK) to Dose Area Product (DAP). While systems are configured to display AKR/CAK when leaving the factory, changing the display to DAP does not comply with 21CFR 1020.32(k). This regulation requires fluoroscopic equipment manufactured on or after June 10, 2006, to display continuous updates of AKR and CAK values.
The affected units were distributed nationwide. Users of these systems should contact GE Healthcare for further instructions regarding the compliance issue.
The recalled product
- Product
- The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac…
- Manufacturer
- Ge Healthcare
- Affected units
- 221
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- OEC 9800
- OEC 9900 Elite
Distribution
Distributed nationwide across the United States.
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