Recall Z-3026-2011 ยท BXB Exerciser, Powered
Alter-G, Incorporated
AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower body injury & Neurological conditions.
| Date | Aug 16, 2011 (initiated Jul 15, 2011) |
| Status | Terminated |
| Reason | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
| 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 vi |
| Quantity | 16 potentially affected units |
| Distribution | Nationwide Distribution (USA ) - including the states of: OK and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072887 | G-TRAINER MEDICAL Alter-G, Inc., Jan 25, 2008 |