Device recall
Z-0813-2011: Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has…
FDA device recall · Class II · Spacelabs Healthcare, Llc
Key facts
| Recall number (Z-number) | Z-0813-2011 |
|---|---|
| Recall event | 57348 |
| Product | Blease Sirius Anaesthesia System is a anaesthesia Gas Machine. The system has the capability to mount two anaesthetic vapourisers on the back bar via a demountable system. The delivery of anaesthetic agent is achieved by the rotation of a control knob which actuates a feature designed "shot bold"… |
| Product code | BSZ |
| Recalling firm | Spacelabs Healthcare, Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 28, 2010 |
| 510(k) numbers | K051629 |
| 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