FDASeptember 15, 2017device
Monarch Airway Clearance System, Model 1000, Product Numbers: PMACS1NA (has blue tooth capability only) and PMACS1WI (has WIFI capability). The firm name on the label is Hill-Rom Services Pte. Ltd., Singapore. The Monarch Airway Clearance System, Model 1000, is intended to provide Airway Clearanc...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Monarch Electromagnetic Interference (EMI) may disrupt the operation of implanted pacemakers or implantable cardioverter defibrillators as well as other devices that might be subject to an EMI if they come into direct contact with the Monarch device.
What to do
FDA enforcement status: Terminated
Brands named
hill rom manufacturinghillhill rom
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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