Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035-4190, (800) 333 -6900.
FDA Recall Z-2358-2015 · Posted 2015-08-10
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Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITI
Date Initiated2015-02-02
Date Terminated2015-09-14
Product Quantity1,057 finished devices
Reason for Recall
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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 to the countries of : AUSTRALIA, CANDA, FRANCE, NEW ZEALAND, SOUTH AFRICA, TRINIDAD AND TOBAGO
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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