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Recall Observatory FDA recall evidence

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).

Z-1947-2020

February 13, 2020

Class II

Product summary

Firm
Sunrise Medical (US) LLC
Event
Event 85431
Status
Terminated
Classification
Class II
Quantity
1
Official record key
device-enforcement:Z-1947-2020

Official wording

Reason: 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.

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.

Distribution pattern: Distributed to US Consignee in MT.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.