Medical Device Recall: Z-0022-05

FDA Recalls dataset · Firm: Independence Technology LLC · Status: Terminated

Recall Action Class: N/A Date Initiated: 2004-08-30 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0022-05.

Recall Res Number
Z-0022-05
Recalling Firm / Manufacturer
Independence Technology LLC
FEI Number
3003508375
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2004-08-30
Date Posted
2004-10-19
Date Terminated
2005-04-01
Product Code
IMK
Event Number
29703
Product Quantity
81 chairs
Product Description iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class III restricted medical device.
Reason for Recall Rocks and debris can enter into the wheel cluster housing through a damaged wheel cap causing wheel malfunction.
Action Details 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.
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.
Code Information / Serial Numbers Catalog No.''s IT000101-IT000148 (inclusive), Vehicle Identification Numbers (''VIN''s):  020404-000347, 020104-000309, 020504-000357, 021203-000308, 020204-000331, 020104-000314, 020104-000318, 021203-000301, 020304-000335, 020104-000310, 020404-000341, 021203-000299, 020204-000330, 020104-000322, 020204-000332, 020404-000350, 020404-000348, 020304-000340, 020404-000346, 020404-000342, 021203-000307, 020204-000333, 020104-000319, 021203-000304, 020404-000352, 020304-000337, 020304-000336, 020504-000356, 020404-000349, 021203-000305, 020604-000360, 020104-000317, 021203-000306, 020504-000358, 020404-000345, 020504-000354, 020304-000334, 020304-000338, 020404-000344, 020404-000351, 020504-000355, 020104-000323, 020104-000324, 021103-000291, 021203-000300, 020304-000339, 020404-000343, 020504-000359, 020604-000363, 020604-000364, 020604-000365, 020604-000366, 020604-000367, 020604-000368, 020604-000362, 021103-000290, 021103-000295, 020104-000315, 020104-000316, 020104-000320, 020104-000311, 020104-000313, 020204-000329, 020504-000353, 020104-000312, 020604-000361, 021003-000280, 020204-000328, 020104-000321, 020204-000326, 021203-000297, 021203-000298, 021203-000303, 020204-000327, 021103-000294, 021103-000286, 021103-000287, 021003-000273, 021103-000282, 021103-000292, 021103-000293, 021003-000276, 021003-000277, 021103-000285, 021103-000289, 020204-000325, 021103-000296, 021003-000278, 021003-000281, 021003-000272, 021003-000279, 021003-000274, 021003-000275, 021103-000283, 021103-000288, 021103-000284, 021203-000302.

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