Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power
FDA device recall Z-1947-2020 · posted 2020-05-11 · Terminated
Recall details
- Recalling firm
- Sunrise Medical (US) LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Software Design Change
- Status
- Terminated
- Product code
- ITI
- Quantity affected
- 1
- Distribution
- Distributed to US Consignee in MT.
- Date initiated
- 2020-02-13
- Date posted
- 2020-05-11
- Date terminated
- 2021-04-28
- Location
- Fresno, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Quickie, Zippie (K142457) | Sunrise Medical (Us), LLC | 2014-12-18 |