Recall Z-1441-2015 ยท KPY Shield, Protective, Personnel
GE Healthcare
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
| Date | Apr 13, 2015 (initiated Mar 9, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Equipment maintenance |
| 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. |
| Quantity | 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, FINLAND, FRANCE, UNITED KINGDOM, GUYANA, IRELAND, ISRAEL, ITALY, NIGERIA and NORWAY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.