Device recall: Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blanke
MWT Materials, Inc. (Passaic, NJ) initiated this device recall on 6 Oct 2014; FDA lists 11 product records under event 72202, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 13 Jul 2021. Initiation: voluntary: firm initiated. This is the only enforcement event on this register for MWT Materials, Inc..
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
MWT Materials, Inc., Passaic, NJ.
Reason for recall
"When not used correctly, Accusorb MRI products may overheat and lead to patient injury."
Distribution
"US Nationwide Distribution in the states of NY and MA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0663-2016 | Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 49 units | Class II | Terminated | 27 Jan 2016 |
| Z-0664-2016 | 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. | 31 units | Class II | Terminated | 27 Jan 2016 |
| Z-0665-2016 | Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | one unit | Class II | Terminated | 27 Jan 2016 |
| Z-0666-2016 | Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 6 units | Class II | Terminated | 27 Jan 2016 |
| Z-0667-2016 | Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 15 units | Class II | Terminated | 27 Jan 2016 |
| Z-0668-2016 | 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. | 14 units | Class II | Terminated | 27 Jan 2016 |
| Z-0669-2016 | Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 18 units | Class II | Terminated | 27 Jan 2016 |
| Z-0670-2016 | Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 5 units | Class II | Terminated | 27 Jan 2016 |
| Z-0671-2016 | Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 47 units | Class II | Terminated | 27 Jan 2016 |
| Z-0672-2016 | Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 1 units | Class II | Terminated | 27 Jan 2016 |
| Z-0673-2016 | Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | 1 unit | Class II | Terminated | 27 Jan 2016 |
Context
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "When not used correctly, Accusorb MRI products may overheat and lead to patient injury."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of NY and MA."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 13 Jul 2021. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.