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U.S. Department of Health and Human Services

Class 2 Device Recall Cybernet Medical MedStar Telemedicine System

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  Class 2 Device Recall Cybernet Medical MedStar Telemedicine System see related information
Date Initiated by Firm January 23, 2008
Date Posted February 25, 2010
Recall Status1 Terminated 3 on October 22, 2010
Recall Number Z-0854-2010
Recall Event ID 53785
510(K)Number K050951  K020534  
Product Classification Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
Product Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-386.

The device is for a remote medical data collection device for the monitoring of patients by healthcare providers. It is intended to work with a weight scale, spirometer, blood pressure unit and pulse oximeter and to transmit data over a phone line.
Code Information Serial numbers 3812, 3814 and 3824 have not yet been corrected. No others were in need of correction.
Recalling Firm/
Manufacturer		 Cybernet Systems Corp.
727 Airport Blvd
Ann Arbor MI 48108-1639
For Additional Information Contact
734-668-2567
Manufacturer Reason
for Recall		 A software problem renders these devices incapable of capturing lung function, oxygen saturation and pulse data collected from multiple tests in accordance with the instructions for use.
FDA Determined
Cause 2		 Component design/selection
Action The firm sent out a recall letter dated 10/27/09. Consignees were asked to return the devices in prepaid shipping containers. The recalling firm would do a software upgrade and return the device to the consignee. The firm expects it to take 3-6 months to upgrade all devices. Contact Cybernet Medically immediately, at 1-800-CYBERNET, with the serial number and code versions of the devices in question and Cybernet will start the RMA process for returning the devices for the updates, free of cost.
Quantity in Commerce 3
Distribution Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.
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 = DXH and Original Applicant = CIBERNET SYSTEMS CORP.
510(K)s with Product Code = DXH and Original Applicant = CYBERNET MEDICAL
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