Z-1947-2020 Class II Terminated
FDA device recall Z-1947-2020 was initiated by Sunrise Medical (US) LLC on February 13, 2020 and is designated Class II. 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. The recall status is terminated (terminated April 28, 2021). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- February 13, 2020
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
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.
Distribution Pattern
Distributed to US Consignee in MT.
Code Information
Q700M wheelchair S/N Q7MP-083941. UDI:(01)05022408059799. Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). Controller label: D50903.15 CR19100531.