Recall Z-0667-2016 ยท LNH System, Nuclear Magnetic Resonance Imaging
MWT Materials, Inc.
Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
| Date | Oct 6, 2014 |
| Status | Terminated |
| Reason | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. |
| Root cause | Device Design |
| Action | MWT issued a letter dated 10/4/2014 via email to all distributors for further distribution to consignees. Tghe letter identified the affected product, problem and actions to be taken. Questions can be direct to info@MWT-Materials.com. |
| Quantity | 15 units |
| Distribution | US Nationwide Distribution in the states of NY and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.