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Terminated

iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.

FDA Recall Z-1383-04 · Posted 2004-08-24

Recalling FirmIndependence Technology LLC
Recall StatusTerminated
Product CodeIMK
Date Initiated2004-07-01
Date Terminated2005-02-02
Product Quantity81 chairs

Reason for Recall

iBOT Mobility System may tip over due to malfunction in power base.

Firm Action

Initial contact to consignees was by telephone on July 2,3,&4 2004. Letters were sent to all consignees from July 5,6,&8, 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 traning/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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