AlterG Anti-Gravity Treadmill; Alter G, 48349 Milmont Drive, Fremont, Ca 94538 Product Usage: Rehabilitation of lower bo
FDA device recall Z-3026-2011 · posted 2011-08-16 · Terminated
Recall details
- Recalling firm
- Alter-G, Incorporated
- Reason for recall
- Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting.
- Action taken
- 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
- Status
- Terminated
- Product code
- BXB
- Quantity affected
- 16 potentially affected units
- Distribution
- Nationwide Distribution (USA ) - including the states of: OK and TX.
- Date initiated
- 2011-07-15
- Date posted
- 2011-08-16
- Date terminated
- 2011-08-16
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| G-TRAINER MEDICAL (K072887) | Alter-G, Inc. | 2008-01-25 |