The Recall Desk
HighFDA (Devices)·Z-1144-2017·Announced 2017-02-15

Physio-Control Recalls LIFEPAK 15 Defibrillators with Erroneous CO2 Readings

Physio-Control is recalling LIFEPAK 15 Monitor/Defibrillators with End-Tidal CO2 options because the CO2 reading may intermittently display an incorrect value of XXX.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device used in emergency care where a malfunction (erroneous CO2 reading) poses a risk of harm to patients, but the source text does not report any specific injuries, illnesses, or fatalities.

Plain-English summary

Physio-Control, Inc. is recalling the LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. The recall involves 2,584 units total, including 1,501 units in the United States, 1,034 units internationally, and 49 units owned by Physio-Control, as well as 50 modules.

The recall is being issued because the End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation. This device is intended for use by trained medical personnel in out-of-doors and indoor emergency care settings.

Affected devices are distributed worldwide, including in the United States (including Puerto Rico) and numerous international locations. Specific lot numbers for affected modules are 1506, 1520, 1532, 1544, and 1551. A comprehensive list of affected serial numbers is available in the official recall documentation.

The recalled product

Product
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.
Manufacturer
Physio-Control, Inc.
Category
Medical Device — Monitor/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 (20)

  • LOT NUMBERS OF AFFECTED MODULE: Lot # 1506
  • 1520
  • 1532
  • 1544
  • and 1551. SERIAL NUMBERS OF AFFECTED DEVICES: 37930990
  • 38046566
  • 38130282
  • 38200467
  • 38374121
  • 38544771
  • 38561025
  • 38567823
  • 38577667
  • 38763423
  • 38805573
  • 39229417
  • 39656903
  • 39749477
  • 39757723
  • 39905189

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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.

See all 2 products in this recall →

Related recalls

Same manufacturer · Physio-Control, Inc.

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Same hazard · erroneous reading

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