Recall record at a glance
| Official record | Z-1441-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | Apr 22, 2015 |
| Recall initiation date | Mar 9, 2015 |
| Quantity | 797 (3 US, 794 OUS). |
| Location | Waukesha, WI, United States |
Official product description
Kenex Radiation Shield installed with GE Healthcare Interventional, Surgery, CT and X-Ray Imaging systems.
Why the product was recalled
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 information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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