FDA Device recall Z-1706-2014
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems
- FDA Device
- Class II
- terminated
- Published 2014-06-11
On 2014-06-11 the FDA classified a Class II recall of Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems by Ge Healthcare, citing GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1706-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-05-02 |
| Published | 2014-06-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems. Kenex Suspension installed with Radiation shield and lamp with following model numbers: E03971AA;E03981AA;E30421AA;E30431AA;E30591CA;E30591HD;E30591HL;E30591EB;E30511P;E30591AB;E30591B;E30511Q;E30591C;E30591A;E30591RR;E30591CB;E30591E;E33591PA;E33591PC. Product Usage: Personnel protective shield is a device intended for medical purposes to protect the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
Reason
GE Healthcare has recently become aware of a potential safety issue due to the improper installation of a Kenex ceiling suspended radiation shield and surgical lamp. This issue is not related to the design of the Kenex product. The affected products are limited to installations completed or contracted by GE Healthcare. There has been a reported incident of a radiation shield falling from the ceil
Identifiers
| code_info | Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 000002…Mfg Lot or Serial # System ID 00000226588WK2 309655FC1 00000215577WK8 312878WCL 00000224993WK6 318473RCATH2X 00000244933WK8 401274MV2 00000286625WK9 503230CV3 00000199483WK9 619457SCL 00000273112WK3 804862SR7A 00000234084WK2 915563LUADV 00000063736YY3 MCTHKGMN 00000416503WK1 1222 00000299868WK0 215662C3 00000312304WK9 215770C1 00000367696WK2 215861LC 00000312714WK9 301891LC 00000321508WK4 313421LC 00000309562WK7 317818MDI120 00000438039WK0 317818MDI905 00000503165WK3 318462BCL 00000505246WK9 318473RCATH4 00000281715WK3 318494LC1 00000405780WK8 318494LC2 00000405779WK0 401729PCL 00000455944WK9 402280P1 00000492511WK1 407646CL1 00000314328WK6 407896CCCATH 00000378033WK5 480474LC3 00000314429WK2 607763CL1 00000469188WK7 610250SC 00000399463WK9 615778ECL1 00000431048WK8 615781SHCV1 00000466434WK8 617340LC 00000280718WK8 618242GSLC 00000323794WK8 619543UC5 00000409286WK2 636933JMLC 00000320222WK3 708383OPLC 00000506007WK4 801350LC1 00000508243WK3 801350L |
|---|
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-1706-2014%22
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