Recall record at a glance
| Official record | Z-2315-2012 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Toshiba American Medical Systems Inc. |
| Report date | Sep 12, 2012 |
| Recall initiation date | Feb 21, 2012 |
| Quantity | 3 units |
| Location | Tustin, CA, United States |
Official product description
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Why the product was recalled
The firm recalled due to a potentail problem with the position of the hold in the lug teminals on the power cables connected to the terminal blocks on the gradient coil.
Distribution information
US (nationwide) distribution including the states of Ohio and Texas.
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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