FDA recall Z-1947-2020

Sunrise Medical (US) LLC · Class II · device

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 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.

Distribution

Distributed to US Consignee in MT.

Key facts

Status
Terminated
Initiation date
2020-02-13
Report date
2020-05-20
Termination date
2021-04-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Fresno, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2020