Recall Z-1947-2020— Sunrise Medical (US) LLC
Class II · Terminated
Class II FDA medical device recall by Sunrise Medical (US) LLC, initiated 2020-02-13, terminated 2021-04-28. It names one FDA 510(k) clearance: K142457. Product: 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).. 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..
- Recalling firm
- Sunrise Medical (US) LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-13
- Terminated
- 2021-04-28
- Firm location
- Fresno, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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).
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.