Physio-Control Recalls LIFEPAK 12 Defibrillators with Erratic CO2 Readings
Physio-Control is recalling LIFEPAK 12 Defibrillators because the End-Tidal CO2 reading may intermittently display an invalid value of XXX during operation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 12 Defibrillator/Monitor with the End-Tidal CO2 option. The recall involves 7 units in the United States and 13 modules worldwide. The devices are used in hospital settings, including emergency departments, critical care, and operating rooms, as well as for in-hospital and out-of-hospital transport.
The recall is due to a defect where the End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. This issue affects specific modules with Lot numbers 1520 and 1544, and devices with serial numbers 32877820, 34356891, 35984435, 37223110, 37440401, 37456675, and 37913307.
The affected devices were distributed in the US states of Alabama, Georgia, New York, and South Carolina, as well as in Australia. Users should contact Physio-Control for instructions on how to address the issue.
The recalled product
- 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
- Manufacturer
- Physio-Control, Inc.
- Category
- Medical Device — Defibrillator
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 34356891
- 35984435
- 37223110
- 37440401
- 37456675
- and 37913307.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Physio-Control, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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