GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Cable Breakage Risk
GE Healthcare is recalling Proteus XR/a X-ray systems because a steel cable supporting the bucky device may break. A falling bucky could injure a patient or operator.
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 where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling 192 units of the Proteus XR/a with wall stand (model number 2260354). These devices are intended for generating radiographic images of human anatomy in general diagnostic procedures and are not intended for mammographic applications.
The recall is due to a potential breakage of the steel cable that supports the bucky device in certain wall stands. If the bucky falls while the system is in use, it could result in an injury to a patient or operator.
The affected units were distributed worldwide, including nationwide in the United States and in 21 other countries. The source text does not specify instructions for consumers or healthcare providers on how to proceed with the recall.
The recalled product
- Product
- GE Healthcare Proteus XR/a with wall stand model number 2260354. Intended for use in generating radiographic images of human anatomy in all general purpose diagnostic procedures. This device is not intended for mammographic applications.
- Manufacturer
- GE Healthcare
- Hazard
Distribution
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