Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication
Compass Health Brands (Corporate Office)
Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches.
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class I - Dangerous
Product design change did not receive proper premarket clearance and lacks a 510 (k)
A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility.