FDA Medical Device Recalls (openFDA)
Cybernet Systems Corp.: Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. 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 number
- Z-0853-2010
- Recalling firm
- Cybernet Systems Corp.
- Product
- Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-380. 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.
- Status
- Terminated
- Initiated
- 2008-01-23
- Posted
- 2010-02-25
- Terminated
- 2010-10-22
- Reason
- 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.
- Root 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
- 24
- Distribution
- Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.
- Lot, serial or model codes
- Serial number range affected is 3554 through 3798. Serial numbers 3554, 3559, 5375, 3579, 3584, 3586, 3587, 3594, 3615, 3655, 3664, 3669 ,3670, 3676, 3680, 3682, 3683, 3694, 3696, 3703, 3708, 3725, 3744 and 3798 have not yet been corrected.
- 510(k) numbers
- ["K020534","K050951"]
- PMA numbers
- not on file
- Product code
- DXH
- Firm FEI
- 3004198411
- Firm city
- Ann Arbor
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28