FDA Medical Device Recalls (openFDA)
MWT Materials, Inc.: Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
- Recall number
- Z-0665-2016
- Recalling firm
- MWT Materials, Inc.
- Product
- Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
- Status
- Terminated
- Initiated
- 2014-10-06
- Posted
- not on file
- Terminated
- 2021-07-13
- Reason
- When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
- Root cause
- Device Design
- Action
- MWT issued a letter dated 10/4/2014 via email to all distributors for further distribution to consignees. Tghe letter identified the affected product, problem and actions to be taken. Questions can be direct to info@MWT-Materials.com.
- Quantity
- one unit
- Distribution
- US Nationwide Distribution in the states of NY and MA.
- Lot, serial or model codes
- All
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 3004863903
- Firm city
- Passaic
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28