Device Recall Flexicair MC3

MC3, Serial numbers: IC xxxxxx (where xxxxxxx is a 6-digit number sequence).

Physical Medicine Devices

2

No

Product is distributed through rental and sale nationwide, Canada, Austria, Germany and the U.K.

FLEXICAIR MC3¿ Low Airloss Therapy unit

All Serial numbers. The devices have a nomenclature for each respective product model where the serial number is IBxxxxxx, where xxxxxx is a six digit number. The prefix IB is representative of a Flexicair II, prefix IC is representative of a Flexicair MC3 and a six digit number without a prefix is representative of a refurbished Flexicair MC 3.

Physical Medicine Devices

2

No

Nationwide Distribution including CA, FL, GA, IL, MI , MS, NJ, NY, OH and PA

Flexicair¿ MC3 (Model number: M4000) Low Airloss Therapy Units || For use to prevent pressure sore development and wound deterioration in patients who have significant risk of developing these problems and who generally also have one or more to the following conditions: immobility, incontinence, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue, or multi-system failure.