| Class 2 Device Recall Cybernet Medical MedStar Telemedicine System | |
Date Initiated by Firm | January 23, 2008 |
Date Posted | February 25, 2010 |
Recall Status1 |
Terminated 3 on October 22, 2010 |
Recall Number | Z-0852-2010 |
Recall Event ID |
53785 |
510(K)Number | K020534 K050951 |
Product Classification |
Transmitters and receivers, electrocardiograph, telephone - Product Code DXH
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Product | Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-210.
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 range affected was 2778 through 4085. Serial numbers 2826, 3719, 3726, 4045 and 4048 have not yet been corrected. |
Recalling Firm/ Manufacturer |
Cybernet Systems Corp. 727 Airport Blvd Ann Arbor MI 48108-1639
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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 | 60 |
Distribution | Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia. |
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 = DXH 510(K)s with Product Code = DXH
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