GE Healthcare Recalls Kenex Ceiling Suspended Radiation Shields and Lamps
GE Healthcare is recalling Kenex ceiling suspended radiation shields and surgical lamps due to improper installation. A reported incident involved a shield falling from the ceiling.
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 an incident of a radiation shield falling from the ceiling, which constitutes a significant injury risk and falls under the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
GE Healthcare, LLC is recalling Kenex ceiling suspended radiation shields and surgical lamps installed with GE Healthcare Interventional, Surgery, CT, and X-Ray Imaging systems. The recall is due to a potential safety issue caused by the improper installation of these devices. This issue is not related to the design of the Kenex product itself.
The affected products are limited to installations that were completed or contracted by GE Healthcare. The source text notes a reported incident of a radiation shield falling from the ceiling. The recall covers 3,221 units, with 108 units in the US and 3,113 units outside the US, distributed worldwide.
Healthcare facilities should contact GE Healthcare to verify if their specific installation is affected and to arrange for corrective action. The recall number is Z-1706-2014.
The recalled product
- Product
- Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers…
- Manufacturer
- GE Healthcare, LLC
Distribution
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