MWT Materials Recalls Accusorb MRI Leg Wraps Due to Overheating Risk
MWT Materials, Inc. is recalling 18 Accusorb MRI Leg Wraps 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 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 yet 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 18 units of the Accusorb MRI MAC7005 Leg Wrap (Part Number: MRI-05). These products are radio frequency shielding blankets and body-part covers designed for use in the MRI environment. 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. No specific lot numbers or dates of manufacture are provided in the source text.
Consumers and healthcare facilities should stop using the affected Accusorb MRI Leg Wraps immediately. MWT Materials, Inc. is the recalling firm responsible for the recall.
The recalled product
- Product
- Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap 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
- 18
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
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- 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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