Drug recall
Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors…
FDA recall event 71233 · Class II · Spacelabs Healthcare Inc
Key facts
| Event ID | 71233 |
|---|---|
| Recall numbers | Z-1608-2015 |
| Recalling firm | Spacelabs Healthcare Inc |
| Product type | Devices |
| Products | Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective… |
| Initiation date | May 8, 2015 |
| Report date | May 20, 2015 |
| Termination date | Nov 5, 2015 |
| City | Snoqualmie |
| State | WA |
| Country | United States |
| FEI number | 3010157426 |
At a glance
- 1–9 Products in this recall
- 10–99 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: