Device recall
Z-0855-2010: Cybernet Medical MedStar Telemedicine System, Manufactured by Cybernet Medical…
FDA device recall · Class II · Cybernet Systems Corp.
Key facts
| Recall number (Z-number) | Z-0855-2010 |
|---|---|
| Recall event | 53785 |
| 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… |
| Product code | DXH |
| Recalling firm | Cybernet Systems Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2010 |
| 510(k) numbers | K020534, K050951 |
| FEI number | 3004198411 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database