Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging sys

FDA device recall Z-1706-2014 · posted 2014-06-03 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

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

Action taken

GE Healthcare sent an "Urgent Medical Device Correction" letter # 12209 dated May 2, 2014. The letter was addressed to Director of Biomedical Engineering, Director of Radiology and Chief of Cardiology. The letter described the Safety Issue, Safety Instructions, Affected product Details, Product Correction and Contact Information. For questions they should call 1-800-345-2700. For other countries, they should contact their local GE Healthcare Service Representative. .

Root cause

Equipment maintenance

Status

Terminated

Product code

KPY

Quantity affected

3221 (108 US, 3113 OUS).

Distribution

Worldwide Distribution - US Nationwide, ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE,

Date initiated

2014-05-02

Date posted

2014-06-03

Date terminated

2015-02-25

Location

Waukesha, WI