GE Healthcare X-ray Systems Recalled for Loose Power Assist Handle Bolts
GE Healthcare is recalling 810 X-ray systems because internal bolts on the power assist handle may loosen or fall out, potentially causing the handle to stick in the ON position.
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 is classified as FDA Class II, and the hazard involves a mechanical defect that could cause the handle to stick in the ON position, posing a risk of harm to patients or operators, but no injuries or deaths are reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 810 units of Precision 500D, Legacy, RFX, and SFX X-ray systems due to a potential safety issue with the spotfilm device power assist handle. The recall affects 783 units in the United States and 27 units outside the US.
The issue involves internal bolts on the power assist handle that may be loose, loosen, or fall out. If this occurs, it can result in a loss of calibration and offset of the handle, or, under extreme conditions, the handle may stick in the ON position.
The affected systems were distributed worldwide, including the United States (nationwide including DC) and countries such as Australia, Canada, Chile, Germany, Ghana, Guatemala, Iceland, Israel, Italy, Jamaica, Japan, the Russian Federation, the United Arab Emirates, and the United Kingdom. Users should check their serial numbers against the provided list and contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to…
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — X-ray Systems
Distribution
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