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U.S. Department of Health and Human Services

Class 2 Device Recall GTrainer

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  Class 2 Device Recall GTrainer see related information
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
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
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
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.
510(K) Database 510(K)s with Product Code = BXB and Original Applicant = ALTER-G, INC.
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