| Class 2 Device Recall GTrainer |  |
Date Initiated by Firm | July 15, 2011 |
Date Posted | August 16, 2011 |
Recall Status1 |
Terminated 3 on August 16, 2011 |
Recall Number | Z-3026-2011 |
Recall Event ID |
59408 |
510(K)Number | K072887 |
Product Classification |
Exerciser, powered - Product Code BXB
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Product | AlterG Anti-Gravity Treadmill;
Alter G, 48349 Milmont Drive, Fremont, Ca 94538
Product Usage: Rehabilitation of lower body injury & Neurological conditions. |
Code Information |
Model # Model M320: Serial Numbers: FIT00574, FIT00631, FIT00599, FIT00575, FIT00624, FIT00628, FIT00699, FIT00860, FIT00859, FIT00857, FIT00611, FIT00632, FIT00738, FIT00777, FIT00779, FIT00847. |
Recalling Firm/ Manufacturer |
Alter-G, Incorporated 48438 Milmont Dr Fremont CA 94538-7326
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For Additional Information Contact | David Tjon 510-270-5369 |
Manufacturer Reason for Recall | Potential installation error on AlterG Anti-Gravity Treadmill that could cause greater than expected unweighting. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = BXB
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