The Recall Desk
SevereFDA (Devices)·Z-0665-2016·Announced 2016-01-27

MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products

MWT Materials, Inc. is recalling Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of patient injury due to overheating, which aligns with the rubric criteria for a Severe rating (score 4) involving significant injury reports or high-risk device defects.

Plain-English summary

MWT Materials, Inc. is recalling Accusorb MRI radio frequency shielding blankets and body-part covers, including the MAC7004 model (Part Number: MRI-04) and the MRI-Poncho. These products are used in the MRI environment for radio frequency shielding.

The recall is being conducted because the products may overheat when not used correctly, which can lead to patient injury. The agency has classified this as a Class II recall.

The products were distributed in the United States, specifically in the states of New York and Massachusetts. Consumers and healthcare facilities should stop using the affected products and contact the recalling firm for further instructions.

The recalled product

Product
Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 11 recalled by MWT Materials, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 11 products in this recall →