GE Healthcare Recalls Improperly Installed Ceiling Suspended Radiation Shields
GE Healthcare is recalling 797 ceiling-suspended pendent systems for radiation shields and surgical lamps due to improper installation. One incident of a shield falling and causing a minor injury has been reported.
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 involves a risk-of-harm product (falling heavy equipment) where injury has been reported (minor injury), but no serious injury or death is documented, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
GE Healthcare is recalling 797 units of ceiling-suspended pendent systems that support radiation shields and/or surgical lamps. These systems are installed with GE Healthcare Interventional, Surgery, CT, and X-Ray Imaging systems. The recall is due to improper installation where the pendent system was not installed per specified installation requirements.
The affected units were distributed worldwide, including in the United States (California and Massachusetts) and numerous international locations such as Spain, India, Japan, and Germany. A total of 797 units are involved, with 3 in the US and 794 outside the US.
There has been one reported incident where a radiation shield fell from the ceiling, causing a minor injury. Consumers and healthcare facilities should check their installation records against the specific serial and system IDs listed in the official recall notice to determine if their equipment is affected.
The recalled product
- Product
- Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
- Manufacturer
- GE Healthcare
Distribution
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