Drug recall
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia…
FDA recall event 66727 · Class II · Spacelabs Healthcare, Llc
Key facts
| Event ID | 66727 |
|---|---|
| Recall numbers | Z-0351-2014 |
| Recalling firm | Spacelabs Healthcare, Llc |
| Product type | Devices |
| Products | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component. |
| Initiation date | Oct 17, 2013 |
| Report date | Nov 27, 2013 |
| Termination date | Apr 2, 2014 |
| City | Snoqualmie |
| State | WA |
| Country | United States |
| FEI number | 3023361 |
At a glance
- 1–9 Products in this recall
- None 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: