Drug recall
SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a…
FDA recall event 67781 · Class I · Del Mar Reynolds Medical, Ltd.
Key facts
| Event ID | 67781 |
|---|---|
| Recall numbers | Z-1442-2014 |
| Recalling firm | Del Mar Reynolds Medical, Ltd. |
| Product type | Devices |
| Products | SpaceLabs Arkon Anesthesia Delivery System with Version 2.0 Software installed. This system includes a ventilator. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The System may go into a controlled failed state if a series of parameters on the user interface are activated in a specific sequence. |
| Initiation date | Mar 10, 2014 |
| Report date | Apr 23, 2014 |
| Termination date | Aug 20, 2014 |
| City | Hertford |
| Country | United Kingdom |
| FEI number | 3002807992 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: