Physio-Control Recalls
35 recalls on record in the United States
Physio-Control, Inc. recalls LIFEPAK 20e DEFIBRILLATOR/MONITOR, 3201273 Product Usage:
Physio-Control is aware that some devices have had power-related failures as customers prepared their device for initial deployment or during use within the first year of distribution. The symptoms of these failures may include unexpected power on and power off, device lock-up, or a failure to power on or off, any of which has the potential to result in a failure to deliver therapy to the patient and serious injury or death.
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Physio-Control, Inc. recalls LIFEPAK(R) Electrode Starter Kits, Catalog # 11101-000017, M
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
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Physio-Control, Inc. recalls LIFEPAK(R) defibrillation electrodes, Catalog # 11101-000016
The infant artwork on the product instructs incorrect pad placement. Also, the artwork is missing the Type BF Patient connection and High Voltage Warning symbols.
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Physio-Control, Inc. recalls The LIFEPAK 1000 defibrillator is intended for use by person
The firm has received complaints that the LIFEPAK 1000 Defibrillator is unexpectedly powering off during device usage.
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Physio-Control, Inc. recalls LIFEPAK 15 Monitor, Automated External Defibrillator (AED),
The firm has become aware of a potential device issue where the LIFEPAK 15 device may no longer be able to deliver defibrillation energy due to a potential failure of an internal component (Relay) installed on the Therapy Printed Circuit Board Assembly (PCBA).
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Physio-Control, Inc. recalls LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option.
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
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Physio-Control, Inc. recalls LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option.
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
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Physio-Control, Inc. recalls LIFEPAK CR2 Part / Catalog Numbers / UDI-DI code: CR2-2-00
Due to required inspections not being performed on products/units that have gone through servicing.
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Physio-Control, Inc. recalls LIFEPAK 15 Part / Catalog Numbers / UDI-DI code: V15-7-0000
Due to required inspections not being performed on products/units that have gone through servicing.
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Physio-Control, Inc. recalls LIFEPAK 1000 Part / Catalog Numbers / UDI-DI code: 32037150
Due to required inspections not being performed on products/units that have gone through servicing.
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Physio-Control, Inc. recalls LIFEPAK 20e REF 99507-000001 The AED mode is to be used o
Incorrect keypad was incorrectly installed onto a defibrillator/monitor.
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Physio-Control, Inc. recalls LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo¿ RD rainbow
Due to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their monitor/defibrillator system.
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Physio-Control, Inc. recalls LIFEPAK 35 ECG cable REF 11111-000041
Product shipped with incorrect IFU. IFU does not include proper cleaning/disinfection instructions
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Physio-Control, Inc. recalls LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o
Due to an out of tolerance tool being used on monitor/defibrillator systems.
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Physio-Control, Inc. recalls STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERI
Due to customer complaints and out of box failures, the firm is conducting a voluntary recall as a result of product failures (cracks and over-molding separation of the sterilizable internal defibrillation paddles.
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Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibri
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000061, Part Number V15-2-000067
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001373, Part Number V15-7-000002
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and
Their is a potential for battery pins to become loose within the defibrillator resulting in power issues.
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Physio-Control, Inc. recalls HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillat
Semi-automatic defibrillators shipped out by Stryker without battery and electrode packs.
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Physio-Control, Inc. recalls PHYSIO CONTROL LIFEPAK CR2 Defibrillator 3321605-xxx Th
Due to complaints received regarding missing lid magnets which may result in premature battery depletion.
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Physio-Control, Inc. recalls Infant Child Starter Kits, Part Number: 3202784-009, contai
Packaging of infant child reduced energy electrodes was not properly sealed.
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Physio-Control, Inc. recalls Infant/Child Reduced Energy Defibrillation Electrodes, Part
Packaging of infant child reduced energy electrodes was not properly sealed.
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Showing 30 of 35 recalls. See all →