FDA (Devices) recall action 72202
The FDA (Devices) publishes a recall like this one as 11 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 11 pages.
When not used correctly, Accusorb MRI products may overheat and lead to patient injury.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
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.
MWT Materials, Inc. is recalling 14 Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.
MWT Materials, Inc. is recalling 47 units of Accusorb MRI Leg Wrap Blankets because they may overheat when not used correctly, posing a risk of patient injury.
MWT Materials, Inc. is recalling 31 Accusorb MRI arm sleeves distributed in New York and Massachusetts because they may overheat and injure patients when not used correctly.
MWT Materials, Inc. is recalling six Accusorb MRI Breast Shields because they may overheat when not used correctly, posing a risk of patient injury.
MWT Materials, Inc. is recalling five units of Accusorb MRI Large Torso Wraps because they may overheat when not used correctly, posing a risk of patient injury.
MWT Materials, Inc. is recalling Accusorb MRI radio frequency shielding blankets and body-part covers because they may overheat and lead to patient injury when not used correctly.
MWT Materials, Inc. is recalling Accusorb MRI MAC7030 shielding blankets and covers because they may overheat and cause patient injury when not used correctly.
MWT Materials, Inc. is recalling 18 Accusorb MRI Leg Wraps because they may overheat when not used correctly, posing a risk of patient injury.
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.
MWT Materials, Inc. is recalling 49 Accusorb MRI blankets because they may overheat and lead to patient injury when not used correctly.