The Recall Desk
SevereFDA (Devices)·Z-1706-2014·Announced 2014-06-11

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.

What this means for you

Illness, injury, or structural failure has been reported. 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: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591H
Manufacturer
GE Healthcare, LLC

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically: