Medical device recalls Moderate risk

MWT Materials product recalled over fire hazard

Recall date
October 6, 2014
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
MWT Materials, Inc. recalls Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-p…
Recall number
Z-0666-2016
FDA classification
Class II
Brand / firm
MWT Materials, Inc.
Sold / distributed
US Nationwide Distribution in the states of NY and MA.

Why it was recalled

When not used correctly, Accusorb MRI products may overheat and lead to patient injury.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

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