Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

FDA Recall Z-0664-2016 · Posted None

Recalling FirmMWT Materials, Inc.
Recall StatusTerminated
Product CodeLNH
Date Initiated2014-10-06
Date Terminated2021-07-13
Product Quantity31 units

Reason for Recall

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

Firm 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].

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states of NY and MA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑