Drug recall
Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module…
FDA recall event 69406 · Class II · Merge Healthcare, Inc.
Key facts
| Event ID | 69406 |
|---|---|
| Recall numbers | Z-0143-2015 |
| Recalling firm | Merge Healthcare, Inc. |
| Product type | Devices |
| Products | Merge Healthcare, Merge Hemo Programmable diagnostic computer. The system comprises the Patient Data Module and the HeartSuite Hemodynamics Hemo Monitor PC. The two units are connected via a serial… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of… |
| Initiation date | Sep 29, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Aug 25, 2016 |
| City | Hartland |
| State | WI |
| Country | United States |
| FEI number | 1000116130 |
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: