| Date Initiated by Firm |
October 06, 2014 |
| Create Date |
January 21, 2016 |
| Recall Status1 |
Terminated 3 on July 13, 2021 |
| Recall Number |
Z-0672-2016 |
| Recall Event ID |
72202 |
| Product Classification |
System, nuclear magnetic resonance imaging - Product Code LNH
|
| Product |
Accusorb MRI
MAC7010
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 |
1 units |
| Distribution |
US Nationwide Distribution in the states of NY and MA. |
| Total Product Life Cycle |
TPLC 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.
|
