Physio-Control Recalls LIFEPAK 15 Monitor/Defibrillators Due to Display Obstruction
Physio-Control is recalling LIFEPAK 15 monitor/defibrillators with the EtCO2 feature because the respiratory rate display may obscure the leading digit of the EtCO2 value.
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. The hazard involves a display obstruction that could lead to misreading a vital sign, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Physio-Control, Inc. is recalling the LIFEPAK 15 monitor/defibrillator with the End-Tidal CO2 (EtCO2) feature installed. The recall affects units with part numbers V15-2-xxxxxx (software versions 1 and 2) and V15-5-xxxxxx (software version 4). A total of 44,798 units are affected, with 23,189 units in the United States and 21,609 units distributed internationally.
The firm identified that when the EtCO2 feature is configured to the kPa or % setting and the reading is above 9.9 kPa, the display of the respiratory rate may partially obscure a portion of the leading digit of the EtCO2 value. This issue affects all LIFEPAK 15 units with the EtCO2 feature installed and configured to these specific settings.
The device is intended for use by trained medical personnel in outdoor and indoor emergency care settings. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.
The recalled product
- Product
- 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 LIFEPAK 15 monitor/defibrillator is intended for use by trained medical pe
- Manufacturer
- Physio-Control, Inc.
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 (20)
- ***************SERIAL NUMBERS IN THE US ************************ 37241684
- 37870230
- 37870231
- 37870232
- 37870234
- 37870235
- 37870237
- 37870238
- 37870240
- 37870241
- 37870242
- 37870245
- 37900601
- 37923078
- 37923079
- 37923100
- 37923153
- 37923162
- 37923203
- 37923205
Distribution
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