AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.
FDA Recall Z-3026-2011 · Posted 2011-08-16
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Recalling FirmAlter-G, Incorporated
Recall StatusTerminated
Product CodeBXB
Date Initiated2011-07-15
Date Terminated2011-08-16
Product Quantity16 potentially affected units
Reason for Recall
Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
Firm Action
Alter-G, Inc. notified all affected customers by telephone, e-mail and followed by a "Medical Device Customer Advisory Notification" letter dated July 15, 2011. Customers were provided information on the installation error, the potential harm to patients, and the actions to be taken. The letter instructs customers to discontinue use of the Alter G until the recalling firm can evaluate the machine and correct any installation error. The letter states that the recalling firm is planning to visit affected customer's facility as quickly as possible and will contact customers to schedule this visit. Questions or concerns should be directed to David Tjon at 510-270-5369.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution (USA ) - including the states of: OK and TX.
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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