Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is...
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1947-2020 | Class II | Terminated | Voluntary: Firm initiated |
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