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Terminated

iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.

FDA Recall Z-0022-05 · Posted 2004-10-19

Recalling FirmIndependence Technology LLC
Recall StatusTerminated
Product CodeIMK
Date Initiated2004-08-30
Date Terminated2005-04-01
Product Quantity81 chairs

Reason for Recall

Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.

Firm Action

All individuals/organizations in possession of a device were notified by telephone beginning on August 30, 2004. Letters were mailed to all Customers on 8/31/2004 and to all Clinics on 9/1/2004.

Root Cause

Other

Distribution Pattern

The Independence IBOT 3000 Mobility System was distributed to direct customers in the US, the UK, Ireland, and New Zealand. Ten of the US Direct customers received their devices via the VA. One training/demo/assessment device was distributed to the firm''s European support Centre (Ortho Clinical Diagnostics) in France. Two training/demo/assessment devices were distributed to a J&J representative in Japan.

Official Source

View FDA Recall →

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

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