Device recall
Z-2586-2014: ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological…
FDA device recall · Class II · Spacelabs Healthcare Inc
Key facts
| Recall number (Z-number) | Z-2586-2014 |
|---|---|
| Recall event | 69125 |
| Product | ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Physiological patient monitor. Used in a hospital environment. |
| Product code | MHX |
| Recalling firm | Spacelabs Healthcare Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 16, 2014 |
| 510(k) numbers | K121480 |
| FEI number | 3010157426 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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