The Recall Desk
SevereFDA (Devices)·Z-0672-2016·Announced 2016-01-27

MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk

MWT Materials, Inc. is recalling Accusorb MRI MAC7010 radio frequency shielding blankets and body-part covers because they may overheat when not used correctly, posing a risk of patient injury.

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 'Severe' criteria for significant injury reports or high-risk medical device defects.

Plain-English summary

MWT Materials, Inc. is recalling Accusorb MRI MAC7010 products, which are radio frequency shielding blankets and body-part covers designed for use in the MRI environment. The recall is being conducted because the products may overheat when not used correctly, which can lead to patient injury.

The recall covers one unit of the product. Distribution was limited to the United States, specifically in the states of New York and Massachusetts. The recall applies to all codes of the affected product.

Consumers and healthcare facilities should stop using the affected Accusorb MRI MAC7010 products immediately. MWT Materials, Inc. is the recalling firm responsible for managing the recall process.

The recalled product

Product
Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment.
Affected units
1

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 →