Recall Z-2358-2015 ยท ITI Wheelchair, Powered
Invacare Corporation
Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
| Date | Aug 10, 2015 (initiated Feb 2, 2015) |
| Status | Terminated |
| Reason | The batteries used in the Invacare Pronto Air Personal Transporter models power wheelchairs have the possibility to overheat during charging which could potentially result in leaking battery acid and/or swelling battery, loss of use, chemical burns and/or property damage. |
| Root cause | Device Design |
| Action | Invacare sent an " Urgent Medical Device Recall " letter on April 6, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You should immediately contact your provider at the number below so a replacement batteries can be installed. If you have any questions concerning these instructions, please call Invacares recall support line at (877) 413-6008, Monday Friday, 8 a.m. 5 p.m. EST, for assistance. Visit www.invacare.com/recall for more information about this recall. |
| Quantity | 1,057 finished devices |
| Distribution | Worldwide Distribution - US (nationwide) Distribution including Puerto Rico, and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA and WI., and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021680 | INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 Invacare Corp., Jun 18, 2002 |