Recall Z-0022-05 ยท IMK Wheelchair, Stair Climbing
Independence Technology LLC
iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.
| Date | Oct 19, 2004 (initiated Aug 30, 2004) |
| Status | Terminated |
| Reason | Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction. |
| Root cause | Other |
| 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. |
| Quantity | 81 chairs |
| Distribution | 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 D |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.