GE OEC 9900 Elite Mobile Fluoroscopy System Recall for Monitor Fall Risk
GE Healthcare is recalling 453 OEC 9900 Elite mobile fluoroscopy systems because defective screws may cause the workstation monitor to fall forward.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (falling monitor) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
GE Healthcare is recalling 453 units of the OEC 9900 Elite mobile fluoroscopy system. The recall is due to a potential safety issue with the screws that attach the workstation monitor spring arm to the extension arm. This defect may cause the spring arm and monitor to fall forward.
The affected systems were distributed worldwide, including in the United States and various international markets. The product is designed to provide fluoroscopic and spot-film images during diagnostic surgical and interventional procedures.
Consumers and healthcare facilities should contact GE OEC Medical Systems, Inc. for further instructions on how to address this safety issue.
The recalled product
- Product
- The OEC 9900 Elite mobile fluoroscopy system (image intensified fluoroscopic x-ray) is designed to provide fluoroscopic and spot-film images of the patient during diagnostic surgical and interventional procedure. Examples of clinical application may include cholangiography…
- Manufacturer
- GE OEC Medical Systems, Inc
- Hazard
- Affected units
- 453
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 (1)
- Model Numbers - OEC 9900 Elite
Distribution
Distribution scope not specified by the agency.
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