Medical Device Field Correction - December 2014Product: Invacare® G29 Full-Length Rails Mounting Brackets
Model number: G29
Invacare has recently identified a supplier quality issue during a self-audit. The rail mounting bracket that attaches the G29 full length bed rail to the G5510 Bed is out of specification, which may increase the risk of entrapment between the side rail and the headboard. G29 full length bed rails and G-Series beds are designed, manufactured and labeled to be compliant with IEC 60601-2-52. With the out of specification bracket the G29 full length bed rail meets the FDA Guidance to Reduce Entrapment1, however it does not meet IEC 60601-2-52 guidelines.
Medical Device Field Correction - September 2014
Invacare determined that a defective sieve bed subassembly in Invacare® Perfecto2 V Oxygen Concentrator or IRC5PO2V Service Part (1165099) enabled zeolite sieve dust from the sieve beds to migrate into the valves of the manifold assembly and muffler causing a reduction in oxygen concentration.
For service or more information regarding field corrections, please contact your local Invacare dealer. To locate a dealer in your area, utilize our Dealer Locator or call Invacare: US - 800-333-6900 or Canada - 800-668-5324 to speak with a customer service representative.