GE Healthcare Recalls Mobile X-Ray Units Due to Erratic Drive Performance
GE Healthcare is recalling Optima and Brivo mobile x-ray units because of erratic drive performance. The recall affects 458 units distributed worldwide.
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 mechanical defect (erratic drive performance) in a medical device that poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling specific models of mobile x-ray units, including the Optima XR220amx, Optima XR200amx, and Brivo XR285amx systems. These devices are indicated for general-purpose diagnostic radiographic examinations for adult and pediatric patients.
The recall was initiated due to a defect described as "Erratic Drive Performance." A total of 458 units are affected, with 306 located in the United States and 152 outside the US. The units were distributed nationwide in the US and in various countries including Canada, Germany, Japan, and the United Kingdom.
The source text does not specify the exact corrective action or instructions for consumers or healthcare facilities. No injuries or illnesses have been reported in the provided text.
The recalled product
- Product
- GE Healthcare, Optima XR220amx, Optima XR200amx, and Brivo XR285amx. The series are indicated for use on adult and pediatric patients for general-purpose diagnostic radiographic examinations and procedures. The systems are indicated for taking radiographic exposures of the…
- Manufacturer
- GE Healthcare, LLC
- Hazard
Distribution
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