FDA-Device2016-01-27Class II

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

MWT Materials, Inc.
Hazard

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

Sold states
US Nationwide Distribution in the states of NY and MA.
Affected count
6 units
Manufactured in
90 Dayton Ave Ste 6E Building 21, N/A, Passaic, NJ, United States
Products
Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2016

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