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U.S. Department of Health and Human Services

Class 2 Device Recall Accusorb

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 Class 2 Device Recall Accusorbsee related information
Date Initiated by FirmOctober 06, 2014
Create DateJanuary 21, 2016
Recall Status1 Terminated 3 on July 13, 2021
Recall NumberZ-0668-2016
Recall Event ID 72202
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductAccusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Code Information All
Recalling Firm/
Manufacturer
MWT Materials, Inc.
90 Dayton Ave Ste 6E Building 21
Passaic NJ 07055-7014
For Additional Information ContactMr. Michael M. Katz
973-472-5161
Manufacturer Reason
for Recall
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
FDA Determined
Cause 2
Device Design
ActionMWT 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 in Commerce14 units
DistributionUS Nationwide Distribution in the states of NY and MA.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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