Recall Z-1947-2020 ยท ITI Wheelchair, Powered
Sunrise Medical (US) LLC
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966).
| Date | May 11, 2020 (initiated Feb 13, 2020) |
| Status | Terminated |
| Reason | Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits. |
| Root cause | Software Design Change |
| Action | An URGENT: MEDICAL DEVICE RECALL letter was sent the firm's dealer. The dealer was instructed on February 4, 2020, to replace the controller unit for the device. |
| Quantity | 1 |
| Distribution | Distributed to US Consignee in MT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142457 | Quickie, Zippie Sunrise Medical (Us), LLC, Dec 18, 2014 |