MWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk
MWT Materials, Inc. is recalling Accusorb MRI MAC7030 shielding blankets and covers because they may overheat and cause patient injury when not used correctly.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk of patient injury from overheating, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
MWT Materials, Inc. is recalling Accusorb MRI MAC7030 radio frequency shielding blankets and body-part covers. These products are used in the MRI environment. The recall covers 1 unit distributed in New York and Massachusetts.
The recall was issued because the products may overheat when not used correctly, which can lead to patient injury. No specific number of affected units or reported injuries is provided in the source text.
Consumers and healthcare facilities should stop using the affected products and contact MWT Materials, Inc. for further instructions on the recall.
The recalled product
- Product
- Accusorb MRI MAC7030 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 →- SevereMWT Materials Recalls Accusorb MRI Shielding Blankets Due to Overheating Risk
FDA (Devices) · 2016-01-27
- 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
FDA (Devices) · 2016-01-27
- HighMWT Materials Recalls Accusorb MRI Arm Sleeves Due to Overheating Risk
FDA (Devices) · 2016-01-27
- HighMWT Materials Recalls Accusorb MRI Breast Shields Due to Overheating Risk
FDA (Devices) · 2016-01-27
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