Recall Z-1706-2014— GE Healthcare, LLC

Class II FDA medical device recall by GE Healthcare, LLC, initiated 2014-05-02, terminated 2015-02-25. FDA's recall record names no specific 510(k) clearance for this event. 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;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.. Reason: GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceil.

Recalling firm

GE Healthcare, LLC

Classification

Class II

Status

Terminated

Initiated

2014-05-02

Terminated

2015-02-25

Firm location

Waukesha, WI, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.