Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-3026-2011

AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538

AlterG, Incorporated / initiated 2011-07-15 / Terminated / root cause: design

Alter-G, Incorporated began a recall of AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions on . The reason FDA records is "Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-3026-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
AlterG, Incorporated
Product
AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.
Product code
BXB Exerciser, Powered
Reason for recall
Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
Root cause tag
design
FDA root cause
Device Design
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.
Quantity in commerce
16 potentially affected units
Distribution
Nationwide Distribution (USA ) - including the states of: OK and TX.
Product codes and lots
Model # Model M320: Serial Numbers: FIT00574, FIT00631, FIT00599, FIT00575, FIT00624, FIT00628, FIT00699, FIT00860, FIT00859, FIT00857, FIT00611, FIT00632, FIT00738, FIT00777, FIT00779, FIT00847.