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.
Other recalls by Physio Control
- LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-0019…
FDA Device · Class II · 2026-05-13 · Physio Control - PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI code: 00721902629013 Catalog Numbe…
FDA Device · Class II · 2026-03-18 · Physio Control - LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-001451 99512-001434 883873785911 LIFEPAK CR2: The LIFEPAK CR2 defibrillator is indi…
FDA Device · Class II · 2025-09-10 · Physio Control - LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-000022 / 99577-001957 / 883873871690 V15-2-000051 / 99577-000046 / 883873988022 V15-…
FDA Device · Class II · 2025-09-10 · Physio Control - LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 320371500023 / 99425-000025 / 885074698953 320371500229 / 99425-000025 / 885074698953 33…
FDA Device · Class II · 2025-09-10 · Physio Control
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.