Drug recall
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx…
FDA recall event 73473 · Class II · Physio-Control, Inc.
Key facts
| Event ID | 73473 |
|---|---|
| Recall numbers | Z-1993-2016 |
| Recalling firm | Physio-Control, Inc. |
| Product type | Devices |
| Products | LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a… |
| Initiation date | Jan 27, 2016 |
| Report date | Jun 22, 2016 |
| Termination date | Mar 31, 2017 |
| 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: