Recall record at a glance
| Official record | Z-1623-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | GE Healthcare |
| Report date | May 27, 2015 |
| Recall initiation date | Apr 22, 2015 |
| Quantity | 4 USA |
| Location | Waukesha, WI, United States |
Official product description
CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. Designed to be a head and whole body CT scanner utilizing a new solid state detector.
Why the product was recalled
GE Healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain Lightspeed 16 CT scanner or PET/CT DST Scanner.. In the unlikely event that the component becomes loose on the CT gantry during operation, it could result in serious bodily injury if the component were expelled. There were no incidents or injuries reported as a res
Distribution information
Distributed to the states of MN, FL & TX.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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