Date Initiated by Firm | October 06, 2014 |
Create Date | January 21, 2016 |
Recall Status1 |
Terminated 3 on July 13, 2021 |
Recall Number | Z-0668-2016 |
Recall Event ID |
72202 |
Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
Product | Accusorb 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 Contact | Mr. 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 |
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 in Commerce | 14 units |
Distribution | US Nationwide Distribution in the states of NY and MA. |
Total Product Life Cycle | TPLC Device Report |
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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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