Reported Jun 11, 2014 · Terminated
Kenex Radiation Shield and surgical lamps installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging…
GE Healthcare, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
19 of 19 products
| # | Product as published |
|---|---|
| 1 | 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 |
| 2 | E03981AA |
| 3 | E30421AA |
| 4 | E30431AA |
| 5 | E30591CA |
| 6 | E30591HD |
| 7 | E30591HL |
| 8 | E30591EB |
| 9 | E30511P |
| 10 | E30591AB |
| 11 | E30591B |
| 12 | E30511Q |
| 13 | E30591C |
| 14 | E30591A |
| 15 | E30591RR |
| 16 | E30591CB |
| 17 | E30591E |
| 18 | E33591PA |
| 19 | 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. |
- Lot codes and dates
- Mfg Lot or Serial # System IDMCTHKGMN
00000226588WK2309655FC100000215577WK8312878WCL00000224993WK6318473RCATH2X00000244933WK8401274MV200000286625WK9503230CV300000199483WK9619457SCL00000273112WK3804862SR7A00000234084WK2915563LUADV00000063736YY3
NSCXR81 of 81 codes
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
2,227 of 2,227 codes
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
- Mfg Lot or Serial # System ID
- Amount recalled
- 3221 (108 US, 3113 OUS).
Where it was sold
- Nationwide
- GA
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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