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 - Dianz Capacitor - December 2014Product: Component- Dianz® Capacitor (Manufactured by Xindian Part number 1099804) used in the Invacare® PerfectO2(TM) Oxygen Concentrator. No service parts were impacted in the U.S.
Model numbers: IRC5P & IRC5PO2
Invacare has recently identified a supplier quality issue that potentially impacts certain Invacare® PerfectO2(TM) concentrators. Invacare has learned that the PSI (Pressure Sensitive Interrupter) design for the compressor motor start/run capacitor by one supplier could lead to rupture.
Medical Device Field Correction - January 2015
Product: Invacare® FDX®, TDX® series and Storm Series® power wheelchairs with 20"-24" width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style back
Date Recall Launched: January 16, 2015
Invacare has recently identified a potential pinch point affecting the wiring involving Invacare® FDX®, TDX® series and Storm Series (3G)® power wheelchairs with 20"-24" width configurations with Formula CG Recline seating system (i.e. Tilt/Recline, Tilt/Recline/Elevate, or Recline only) and a conventional style back. There is a possibility that if the slack in the wires is not routed and secured correctly, and with flexing of the back pan under the user's weight, the headrest knob or clamp bracket may pinch, damage or cut the wire creating a hazard. Smoking, sparking, burning or fire may occur if any wire in this area is repetitively pinched at the same location over a period of time. Not all impacted chairs are expected to have slack in the wiring that is not routed and secured correctly.
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.