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.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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.
- Manufacturer
- MWT Materials, Inc.
- Category
- Medical Device — MRI Accessories
- Hazard
- 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
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 →Related recalls
Same manufacturer · MWT Materials, Inc.
See all →- HighMWT Materials Recalls Accusorb MRI Radio Frequency Shielding Blankets
FDA (Devices) · 2016-01-27
- SevereMWT Materials Recalls Accusorb MRI Leg Wrap Blankets Due to Overheating Risk
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- HighMWT Materials Recalls Accusorb MRI Arm Sleeves Due to Overheating Risk
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- HighMWT Materials Recalls Accusorb MRI Breast Shields Due to Overheating Risk
FDA (Devices) · 2016-01-27
- HighMWT Materials Recalls Accusorb MRI Large Torso Wrap Due to Overheating Risk
FDA (Devices) · 2016-01-27
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