Recall Z-0668-2016— MWT Materials, Inc.
Class II · Terminated
Class II FDA medical device recall by MWT Materials, Inc., initiated 2014-10-06, terminated 2021-07-13. FDA's recall record names no specific 510(k) clearance for this event. Product: Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.. Reason: When not used correctly, Accusorb MRI products may overheat and lead to patient injury..
- Recalling firm
- MWT Materials, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-10-06
- Terminated
- 2021-07-13
- Firm location
- Passaic, NJ, United States
Product description
Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.