Class 2 Device Recall Cybernet Medical MedStar Telemedicine System

• Date Initiated by Firm: January 23, 2008
• Date Posted: February 25, 2010
• Recall Status: Terminated on October 22, 2010
• Recall Number: Z-0855-2010
• Recall Event ID: 53785
• 510(K)Number: K020534 K050951
• Product Classification: Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
• Product: Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-381. 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 number 3657. This unit has been corrected.
• FEI Number: 3004198411
• 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: 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: 1
• 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; 510(K)s with Product Code = DXH