Product Wiki · Recalls · U.S. FDA — Device Enforcement

Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield — recall Z-0666-2016

U.S. FDA — Device Enforcement · United States · 2014-10-06 · Class II

As described by U.S. FDA — Device Enforcement: Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0666-2016
Date of alert
2014-10-06
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
MWT Materials, Inc.
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
US Nationwide Distribution in the states of NY and MA.
Reported risk: When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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