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Recall Observatory FDA recall evidence

Device product

Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.

Z-0634-2014

April 16, 2012

Class II

Product summary

Firm
Invacare Corporation
Event
Event 67134
Status
Terminated
Classification
Class II
Quantity
227 Wheelchairs
Official record key
device-enforcement:Z-0634-2014

Official wording

Reason: The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.

Code information: Serial #'s: 11HM005144, 11IM031276-11IM031300, 11IM033659-11IM033718, 11KM011730 & 11KM032583-11KM032722.

Distribution pattern: US Distribution: Michigan only.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The wheels on Tracer IV wheelchairs (Tracer IV 24" seat width, 450 lbs. weight capacity manual wheel chair) were warped and wobbled when rolled.