Drug recall
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the…
FDA recall event 76162 · Class II · Physio-Control, Inc.
Key facts
| Event ID | 76162 |
|---|---|
| Recall numbers | Z-1143-2017, Z-1144-2017 |
| Recalling firm | Physio-Control, Inc. |
| Product type | Devices |
| Products | LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and…, LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended for use by trained medical personnel in out-of-doors and indoor emergency care settings within the environmental conditions… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. |
| Initiation date | Jan 16, 2017 |
| Report date | Feb 15, 2017 |
| Termination date | Sep 11, 2018 |
| City | Redmond |
| State | WA |
| Country | United States |
| FEI number | 3015876 |
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: