MWT Materials Recalls Accusorb MRI Radio Frequency Shielding Products
MWT Materials, Inc. is recalling 15 Accusorb MRI radio frequency shielding blankets and body-part covers. The products 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 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-harm product (potential patient injury from overheating) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
MWT Materials, Inc. is recalling 15 units of Accusorb MRI radio frequency shielding blankets and body-part covers, including the MAC7008 (Part Number: MRI-08) and MRI-Boot models. These products are used in the MRI environment for radio frequency shielding.
The recall was initiated because the products may overheat when not used correctly, which could lead to patient injury. The affected units were distributed nationwide in the United States, specifically in the states of New York and Massachusetts.
Healthcare facilities and consumers who possess these products should stop using them immediately. MWT Materials, Inc. is the recalling firm responsible for the recall action.
The recalled product
- Product
- Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot 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
- 15
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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