Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1947-2020Class II

Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is...

Sunrise Medical, Inc. / initiated 2020-02-13 / Terminated / root cause: software

Sunrise Medical (US) LLC began a recall of Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No... on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-1947-2020
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Sunrise Medical, Inc.
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).
Product code
ITI Wheelchair, Powered
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.
Root cause tag
software
FDA root cause
Software Design Change
Action
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.
Quantity in commerce
1
Distribution
Distributed to US Consignee in MT.
Product codes and 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.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1947-2020
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1947-2020Class IITerminatedVoluntary: Firm initiated