Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG, and TDXSP-MCG To provide mobility to a person restricted to a sitting position.
FDA Recall Z-0930-2009 · Posted 2009-01-27
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Recalling FirmInvacare Corporation
Recall StatusTerminated
Product CodeITI
Date Initiated2007-11-27
Date Terminated2013-08-01
Product Quantity4171 Wheelchairs
Reason for Recall
Invacare has become aware that on some chairs, the stability lock feature may not be engaging properly or consistently. If the stability lock feature does not engage properly, the wheelchair may veer to one side or it may rock forward onto its front riggings.
Firm Action
On 11/27/2007 the firm sent Urgent Field Correction Needed recall notification letters and response forms to their customers informing them of the problem. They instructed their customers to immediately inspect and adjust the Stability Lock feature, distribute the enclosed update to the Owner's Manual to all end-users, and return the enclosed response form notifying them that the inspection and/or adjustments have been completed.
Root Cause
Pending
Distribution Pattern
Worldwide Distribution --- including USA and countries of Canada, Australia, Germany, New Zealand and the United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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