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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
See all 2 products in this recall →Related recalls
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