GE Healthcare Recalls Proteus XR/a X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Proteus XR/a and Revolution XR/d X-ray systems due to a collimator installation error that caused a serious patient injury.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly reports a serious patient injury resulting from a collimator fall, which aligns with the rubric criteria for a score of 4 (Severe) involving significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling 3,460 units of the Proteus XR/a and Revolution XR/d X-ray imaging systems. The recall is due to a potential safety issue involving a collimator installation error that occurred during a service maintenance activity.
The affected devices are intended for generating radiographic images of human anatomy in general diagnostic procedures. The recall covers units distributed worldwide, including the United States and numerous international locations.
A reported incident involving a collimator fall caused a serious patient injury. Healthcare facilities should contact GE Healthcare to arrange for the necessary service corrections to address the installation error.
The recalled product
- Product
- GE Healthcare, Proteus XR/a. Proteus XR/a Intended Use: Is 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, LLC
- Affected units
- 3,460
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC 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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