Food, drugs, devices › Physio-Control, Inc.
Device recall: LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as
FDA enforcement event 76162 is a device recall by Physio-Control, Inc. of Redmond, WA, initiated 16 Jan 2017 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 11 Sep 2018. Initiation: voluntary: firm initiated. Physio-Control, Inc. has 27 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Physio-Control, Inc., Redmond, WA.
Reason for recall
"The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation."
Distribution
"Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1143-2017 | 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 general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and… | 7 units in the US and 13 modules worldwide (5 international; and 8 owned by Physio) | Class II | Terminated | 15 Feb 2017 |
| Z-1144-2017 | 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 specified in the Operating Instructions. | 2584 units total (1501 units in the US; 1034 units international; and 49 units owned by Physio). 50 modules total | Class II | Terminated | 15 Feb 2017 |
Context
Other enforcement events for Physio-Control, Inc.
All 27 events for Physio-Control, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide distribution. LifePak 12 distributed in US states of AL, GA, NY, SC, and in Australia. LifePak 15 distributed nationwide in the US including Puerto Rico and to ALGERIA, ARGENTINA,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 11 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.