Recall Z-1383-04 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. The device is shipped one each per wooden pallet with wooden sides and top retained by reusable bands.
| Date | Aug 24, 2004 (initiated Jul 1, 2004) |
| Status | Terminated |
| Reason | iBOT Mobility System may tip over due to malfunction in power base. |
| Root cause | Other |
| 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. |
| 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 traning/demo/assessment device was distributed to the firm''s European Support Centre (Ortho Clinical Di |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.