FDA Device recall Z-1143-2017
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option
- FDA Device
- Class II
- terminated
- Published 2017-02-15
On 2017-02-15 the FDA classified a Class II recall of LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option by Physio Control, citing the End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1143-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-16 |
| Published | 2017-02-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Physio Control |
| Distribution | US |
Product
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 ground ambulance, in hospital transport, etc.)
Reason
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Identifiers
| code_info | LOT NUMBERS OF AFFECTED MODULE: Lot # 1520 and 1544. SERIAL NUMBERS OF DEVICES: 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2017%22
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