Drug recall
Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor…
FDA recall event 62437 · Class II · Spacelabs Healthcare, Llc
Key facts
| Event ID | 62437 |
|---|---|
| Recall numbers | Z-2019-2012 |
| Recalling firm | Spacelabs Healthcare, Llc |
| Product type | Devices |
| Products | Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, installations with Option C. It is a patient monitor with arrhythmia detection or alarms. The Spacelabs Healthcare Xprezzon Bedside Monitor is… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display… |
| Initiation date | Jun 12, 2012 |
| Report date | Jul 25, 2012 |
| Termination date | Nov 28, 2012 |
| City | Issaquah |
| 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: