Invacare Pronto Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare Way, Elyria, Ohio, 44035
FDA device recall Z-2358-2015 · posted 2015-08-10 · Terminated
Recall details
- Recalling firm
- Invacare Corporation
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 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,
- Date initiated
- 2015-02-02
- Date posted
- 2015-08-10
- Date terminated
- 2015-09-14
- Location
- Elyria, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91 (K021680) | Invacare Corp. | 2002-06-18 |