Z-0672-2016 Class II Terminated
FDA device recall Z-0672-2016 was initiated by MWT Materials, Inc. on October 6, 2014 and is designated Class II. Reason for recall: When not used correctly, Accusorb MRI products may overheat and lead to patient injury. The recall status is terminated (terminated July 13, 2021). Affected quantity: 1 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- October 6, 2014
- Termination Date
- July 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 units
Product Description
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Reason for Recall
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Distribution Pattern
US Nationwide Distribution in the states of NY and MA.
Code Information
All