Recall Z-1947-2020
Sunrise Medical (US) LLC · initiated February 13, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: 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.
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.
FDA-determined cause: Software Design Change
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.
Details
- Recall number
- Z-1947-2020
- Initiated
- February 13, 2020
- Posted by FDA
- May 11, 2020
- Terminated
- April 28, 2021
- Product code
- ITI – Wheelchair, Powered
- Quantity
- 1
- Distribution
- Distributed to US Consignee in MT.
- Recalling firm
- Sunrise Medical (US) LLC, Fresno, CA