Recall record at a glance
| Official record | Z-2135-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Toshiba American Medical Systems Inc. |
| Report date | Jul 13, 2016 |
| Recall initiation date | Apr 14, 2016 |
| Quantity | 33 units |
| Location | Tustin, CA, United States |
Official product description
MEXL-3010/A5- Vantage Titan 3T Magnetic Resonance Imaging System Product Usage: Vantage Titan 3T (MRT-3010, M-Power V3.5) is an open-bore 3T MRI system that permits outstanding image quality without compromising on features or performance. Vantage Titan 3T combines the features of Atlas technology with Open-Bore technology, making patient comfort a priority. To offer an enhanced level of performance, we are crossing over to Toshibas new 3T Conform Technology. Vantage Titan 3T features a patient aperture of 71 cm and Pianissimo noise reduction technology. It comes with a new, fully functional, state-of-the-art interface designed for ease of use.
Why the product was recalled
A potential problem associated to the gradient coil (ASGC) in the Titan 3T MRI System.
Distribution information
US Nationwide Distribution
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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