GE Healthcare Recalls Revolution XR/d X-ray Systems Due to Collimator Fall Risk
GE Healthcare is recalling Revolution XR/d digital radiographic systems because a collimator installation error during maintenance could cause the device to fall and injure patients.
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 criterion for 'Severe' (score 4) involving significant injury reports.
Plain-English summary
GE Healthcare, LLC is recalling 1,053 units of the Revolution XR/d Digital Radiographic imaging system. The recall is due to a potential safety issue involving a collimator installation error that can occur during service maintenance activities. The device is intended for generating radiographic images of human anatomy and is not intended for mammographic applications.
The recall was initiated after a reported incident where a collimator fell, resulting in a serious patient injury. The affected units were distributed worldwide, including the United States (excluding Vermont) and numerous international countries.
Healthcare facilities should contact GE Healthcare to arrange for inspection and correction of the collimator installation to prevent further incidents. Patients and providers should be aware of this safety issue regarding the specific maintenance activity described.
The recalled product
- Product
- GE Healthcare, Revolution XR/d. Revolution XR/d Intended Use: The Revolution XR/d Digital Radiographic imaging system is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general purpose…
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 1,053
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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