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Terminated

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

FDA Recall Z-1441-2015 · Posted 2015-04-13

Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeKPY
Date Initiated2015-03-09
Date Terminated2015-12-21
Product Quantity797 (3 US, 794 OUS).

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.

Firm Action

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

Distribution Pattern

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, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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