Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Check against the official notice below — it lists the full affected range.
GE Healthcare is recalling Kenex Radiation Shields installed with GE Healthcare Interventional, Surgery, CT and X-Ray imaging systems due to improper ceiling installation of the pendent system supporting the radiation shield and/or surgical lamp. The pendent was not installed according to specified installation requirements. One incident has been reported in which a radiation shield fell from the ceiling and caused a minor injury.
Approximately 797 units have been distributed worldwide, including 3 units in the United States (California and Massachusetts) and 794 units internationally across 20 countries including Spain, India, Japan, Germany, France, the United Kingdom, and others. The recall record does not specify what remedy an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. 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. Quantity: 797 (3 US, 794 OUS). Lot/code info: Mfg Lot or Serial # System ID 00000466434WK8 617340LC 00000495821WK1 916734XR 0000HXNN000113 714229INNOVA 00000582921BU3 AZ4001VA01 00000613708BU7 AZ4013VA01 00000619361BU9 AZ1003VA01 00000620211BU3 AZ1003VA02 00000008C20253 BY4069VA01 0000010BC20022 BY4033VA01 0000010BC20031 BY4020VA02 00000397642BU0 BY4026VA01 00000544493BU0 BY4001VA03 00000581696BU2 BY4002VA03 00000426512BU0 BG4549VA01 00000583121BU9 BG4009VA01 00000588252BU7 BG4621VA01 00000609/70813 BG4604VA01 00000619184BU5 BG4639RX01 00000334659BU0 082406060001 00000334724BU2 082416040002 00000446999BU5 082416200006 00000006556GP5 CS1019VA01 00000549712BU8 CS1006VA04 00000549715BU1 600002VA01 00000581737BU4 CS1006VA05 0000L397H00008 CS1081RX02 000DTCE3650705 CS1021RX02 00000434952BU8 EG1003VA01 00000466657BU4 EG1235VA01 00000535385WK9 EG1102VA01 00000560477BU2 EG1741VA01 00000456800BU2 FI1015VA01 00000464655BU0 FI1064VA01 00000524177BU3 FI1017VA02 00000537029BU1 FI1017VA03 00000549714BU4 FI1025VA01 00000576357BU8 FI1314VA02 00000593473BU2 FI1126VA02 00000600318BU0 FI1023VA03 00000000001585 M86323601 00000000LS8-C1 R4211476 00000006443GP6 M4196634 00000011C2A003 A4185526 0000008C2M0006 M9162723 0000009C2M0054 M4198062 00000403124BU1 A4213138 00000420032BU5 M2030707 00000428406BU3 S4160056 00000467451BU1 M2844529 00000477885BU8 M4163030 00000509548BU4 X1347902 00000516767BU1 B1650215 00000530416BU7 M4496941 00000534726BU5 M4183841 00000577527BU5 M4202928 00000581570BU9 A4199383 00000583669BU7 M2812105 00000585910BU3 M416
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.