FDA Device recall Z-1441-2015
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems
- FDA Device
- Class II
- terminated
- Published 2015-04-22
On 2015-04-22 the FDA classified a Class II recall of Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems by Ge Healthcare, citing 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 i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1441-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-09 |
| Published | 2015-04-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | CA, MA |
Product
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
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.
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000466434WK8 617340LC 00000495821WK1 916734XR 0000HXNN000113 714229INNOVA 000005829…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 FI102 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1441-2015%22
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