Z-0667-2016Class II

Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot

Name: Z-0667-2016 Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot
Creator: MWT Materials, Inc.
Published: 2014-10-06
License: https://open.fda.gov/license/

MWT Materials, Inc. / initiated 2014-10-06 / Terminated / root cause: design

FDA source

MWT Materials, Inc. began a recall of Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment on 2014-10-06. FDA classified it as Class II and gives the reason as "When not used correctly, Accusorb MRI products may overheat and lead to patient injury". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0667-2016
Classification: Class II
Status: Terminated
Initiated: 2014-10-06
Posted: 2016-01-21
Terminated: 2021-07-13
Recalling firm: MWT Materials, Inc.
Product: Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Product code: LNH System, Nuclear Magnetic Resonance Imaging
Reason for recall: When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
Root cause tag: design
FDA 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 [email protected].
Quantity in commerce: 15 units
Distribution: US Nationwide Distribution in the states of NY and MA.
Product codes and lots: All

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0667-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0663-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0664-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0665-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0666-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0667-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0668-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0669-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0670-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0671-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0672-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20
Z-0673-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-20

Product code LNH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)