Device product
Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Z-0663-2016
Product summary
- Event
- Event 72202
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 units
- Official record key
device-enforcement:Z-0663-2016
Official wording
Reason: When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Code information: All
Distribution pattern: US Nationwide Distribution in the states of NY and MA.
Derived failure modes
-
Unknown
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.