GE Healthcare Recalls Optima CL 323i Angiographic X-ray Systems
GE Healthcare is recalling seven Optima CL 323i angiographic X-ray systems due to a potential loss of C-arm gantry motion capability.
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 (medical device) where the hazard is a potential loss of motion capability, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
GE Healthcare is recalling seven Optima CL 323i angiographic X-ray systems. These systems are used to generate fluoroscopic and rotational images of human anatomy for diagnostic, interventional, and image-guided surgical procedures.
The recall was initiated because GE Healthcare became aware of a potential safety issue that may result in the loss of C-arm gantry motion capability on fluoroscopic Interventional imaging systems, including the Innova, Optima, and Discovery lines.
The affected units were distributed worldwide, including in the United States and various international markets. The source text does not specify instructions for consumers or healthcare providers regarding the next steps for these devices.
The recalled product
- Product
- GE Healthcare Optima CL 323i. Angiographic X-ray systems used in generating fluoroscopic and rotational images of human anatomy for diagnostic, interventional and image-guided surgical procedures.
- Manufacturer
- GE Healthcare
- Hazard
- Affected units
- 7
Distribution
Part of a larger recall action
This product is one of 13 recalled by GE Healthcare under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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