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.
Recall
- Recall Number
- Z-0855-2010
- Event Number
- 53785
- Firm
- Cybernet Systems Corp.
- FEI Number
- 3004198411
- Product Code
- DXH
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- January 23, 2008
- Posted
- February 25, 2010
- Terminated
- October 22, 2010
- Address
- 727 Airport Blvd, Ann Arbor, MI, 48108-1639
Description
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.
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.
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.
Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.
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