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;E30591
Check against the official notice below — it lists the full affected range.
GE Healthcare has recalled Kenex ceiling-suspended radiation shields and surgical lamps due to improper installation by GE Healthcare during system setup. The safety issue is not related to the product design itself. There has been one reported incident of a radiation shield falling from the ceiling. Approximately 3,221 affected units have been distributed worldwide, with 108 in the US and 3,113 in other countries, across interventional, surgery, CT, and X-ray imaging installations.
The recall affects installations completed or contracted by GE Healthcare. The affected products are identified by specific system IDs and lot codes listed in the recall notice. The source document does not specify a remedy or corrective action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
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
Reason for recall: 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 Distribution: Worldwide Distribution - US Nationwide, ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGAR Quantity: 3221 (108 US, 3113 OUS). Lot/code info: 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 801350LC2 00000309699WK7 815963LC 00000285416WK4 817548ALC 00000273308BU7 901384LCA 00000399610WK5 909824LC2 00000421718WK8 909824LC3 00000475337WK2 910343NHC1 00000373273WK2 941475CL 00000504090WK2 DLPGMH1 00000283982WK7 E16327 00000432874WK6 LIJ201178 00000484098WK9 M27036 00000336973WK3 MCTH050 FMI12209DUM168 NSCXR 00000387613WK3 215221CL3 00000423269WK0 215785SCA 00000500248WK0 813462ADV1 00000215082WK9 316268SFCL 00000249758WK4 713791SCL3X 00000470720WK4 305395B44 00000319310WK9 313745CATH2 00000414277WK4 415428OCCL2 00000459249WK9 5
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.