Atlas FDA

Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite.

FDA device recall Z-1486-06 · posted 2006-09-06 · Terminated

Recall details

Recalling firm
Invacare Corporation
Reason for recall
If the user has chosen to install optional anti-tippers on the chair, the anti-tipper as designed may not be able to bear the stress of repeated or quick loads placed on it, causing the bolt to bend or break.
Action taken
The recalling firm notified all consignees by recall letter sent on or about 7/20/06 along with replacement anti-tippers for each device on hand.
Root cause
Device Design
Status
Terminated
Product code
IOR
Quantity affected
208 wheelchairs
Distribution
Nationwide and Canada.
Date initiated
2006-07-18
Date posted
2006-09-06
Date terminated
2012-03-01
Location
Elyria, OH

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Related 510(k) clearances

RecordFirmDate
KUSCHALL DESIGN K3/K4 SERIES OF MANUAL WHEELCHAIRS (K982336)Invacare Corp.1998-08-21