Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical, Ann Arbor, MI; Model 533-386. The device
FDA device recall Z-0854-2010 · posted 2010-02-25 · Terminated
Recall details
- Recalling firm
- Cybernet Systems Corp.
- 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.
- Action taken
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- DXH
- Quantity affected
- 3
- Distribution
- Nationwide distribution: California, Florida, Georgia, Illinois, Louisiana, Michigan, Mississippi, New York, Oklahoma and West Virginia.
- Date initiated
- 2008-01-23
- Date posted
- 2010-02-25
- Date terminated
- 2010-10-22
- Location
- Ann Arbor, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDSTAR 220, MODEL 533-220; MEDSTAR 230, MODEL 533-230; MEDSTAR 360, MODEL 533-360; MEDSTAR 370, MODEL 533-370 (K050951) | Cibernet Systems Corp. | 2005-07-19 |
| MEDSTAR SYSTEM, MODELS 533-300 (K020534) | Cybernet Medical | 2003-02-11 |