Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.

FDA device recall Z-1441-2015 · posted 2015-04-13 · Terminated

Recall details

Recalling firm

GE Healthcare

Reason for recall

GE Healthcare has recently become aware of an improper installation of a ceiling suspended pendent supporting a radiation shield and/or surgical lamp. The pendent system was not installed per specified installation requirements. There has been a reported incident of a radiation shield falling from the ceiling causing a minor injury.

Action taken

GE Healthcare sent an Urgent Medical Device Correction letter dated March 9, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions in USA contact 1-800-437-1171. For other countries contact your local GE Healthcare Service Representative.

Root cause

Equipment maintenance

Status

Terminated

Product code

KPY

Quantity affected

797 (3 US, 794 OUS).

Distribution

Worldwide Distribution - US Distribution to the states of : CA and MA., and to the countries of : SPAIN, INDIA, JAPAN, AZERBAIJAN, BULGARIA, BELARUS, SWITZERLAND, CZECH REPUBLIC, GERMANY, EGYPT, FINLA

Date initiated

2015-03-09

Date posted

2015-04-13

Date terminated

2015-12-21

Location

Waukesha, WI