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Terminated

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).

FDA Recall Z-1947-2020 · Posted 2020-05-11

Recalling FirmSunrise Medical (US) LLC
Recall StatusTerminated
Product CodeITI
Date Initiated2020-02-13
Date Terminated2021-04-28
Product Quantity1

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.

Firm 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.

Root Cause

Software Design Change

Distribution Pattern

Distributed to US Consignee in MT.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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