Medical Device Field Correction - June 2014
Invacare Pronto M41 TSB: HQ12-09-001
Invacare P/N 1143839
Description: "Controller MK5, NX (40 amp)"
Use: Used on M41 Power Wheelchairs
Invacare® Pronto® M41™ Power Wheelchair controllers obtained through Invacare Service Parts (ISP) have controllers that were programmed in a way that is not aligned to standard factory settings.
Medical Device Field Removal Joystick Recall - October 2013Invacare is conducting a field correction of certain Invacare® Power Wheelchairs equipped with SPJ+ Joysticks or MK6i Driver Controls (excluding all ASL, Sip-n-Puff and Switch Control systems).
Impacted power wheelchair models are determined by the type of joystick and the date the power wheelchair was manufactured by Invacare. Power Wheelchairs with Invacare SPJ+Joystick models manufactured between September 9, 2009 and March 21, 2013 are impacted. Power Wheelchairs with an Invacare MK6i Driver Control (excluding all ASL, Sip-n-Puff and Switch Control systems)manufactured between October 1, 2006 and March 21, 2013 are impacted.
Medical Device Field Correction - October 2013
Aquatec® Ocean VIP, Aquatec® Ocean Dual-VIP and Aquatec® Ocean E-VIP
A field correction is being conducted for the Aquatec® Ocean VIP, Aquatec® Ocean Dual-VIP and Aquatec® Ocean E-VIP distributed between October 1, 2012 and April 30, 2013.
There is a low possibility that the snap-on fixtures can unlatch unintentionally when the product is used in a reclined position. There is a potential for the user to slip through the back if the backrest clip (s) became unlatched. To date Invacare Corporation has not received any reported events involving injury associated with this issue. The U.S. FDA has been notified and is aware that Aquatec and Invacare are voluntarily taking this action.
Model Numbers: 1470793, 1471208 and 1525707 Impacted Serial Numbers
Medical Device Field Correction - September 2012Invacare® Solara® 3G Manual Wheelchairs
NOTE: This applies ONLY in the United States
Impacted Serial Numbers: 12GE003750, 12GE003554 & 12HE001766
Date Recall Launched: September 2012
A field correction is being conducted for Invacare® Solara® 3G manual wheelchairs with serial numbers 12GE003750, 12GE003554, and 12HE001766. The potential exists for the wheel to rotate freely despite engagement of hub brake. On a non-level surface this condition could result in the chair moving in a rotating motion. Normal use conditions involving vehicle lifts or other elevated surfaces would present an increased risk of injury given this condition. Worst case scenario, the wheel may fully unthread from the hub resulting in wheel separation and ultimate device collapse. As a result, the user could potentially fall from the chair and incur serious injury or death.
If the serial number of your Solara® 3G manual wheelchair is listed above, it is important that you contact your provider immediately and make arrangements to have your device corrected. Invacare is providing the necessary parts, and this correction is free of charge.
If for some reason you currently do not have a provider, contact Invacare as shown below so we can assist you in getting your device corrected.
This recall is voluntarily being executed with the knowledge of the U.S. Food and Drug Administration.
Phone (toll free): 800-333-6900
Fax (toll free): 877-619-7996
Mail: Invacare Corporation, Attn: Regulatory Affairs, One Invacare Way, Elyria, OH 44036-2125
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.