GE Healthcare Recalls BrightSpeed X-ray Systems Due to Scan Timing Defect
GE Healthcare is recalling 10,884 BrightSpeed X-ray systems because a defect may cause scans to start before a prescribed delay completes.
What this means for you
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 is classified as FDA Class II. The hazard involves a functional defect in a medical device that could lead to unintended radiation exposure or procedural errors, representing a risk of harm where injury has not yet been reported.
Plain-English summary
GE Healthcare, LLC is recalling 10,884 units of the BrightSpeed X-ray system. The recall was initiated after it was discovered that an issue can result in a scan starting before the prescribed delay has completed.
The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in numerous international locations such as Japan, Mexico, the United Kingdom, and others. The source text does not specify the exact number of units distributed in each specific country.
The source text does not provide specific instructions for consumers or healthcare providers on how to proceed with the recall, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- GE Healthcare BrightSpeed X-ray system
- Manufacturer
- GE Healthcare, LLC
- Affected units
- 10,884
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- n/a
Distribution
Part of a larger recall action
This product is one of 16 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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