Physio-Control Recalls

35 recalls on record in the United States

medical: 35
medical Class I
2018-01-17

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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medical Class I
2017-12-20

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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medical Class I
2017-12-20

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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medical Class I
2017-03-15

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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medical Class I
2017-02-22

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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medical Class II
2017-02-15

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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medical Class II
2017-02-15

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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medical Class II
2025-09-10

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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medical Class II
2025-09-10

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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medical Class II
2025-09-10

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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medical Class II
2025-03-05

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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medical Class II
2025-02-26

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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medical Class II
2025-02-12

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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medical Class II
2024-11-06

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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medical Class II
2024-10-30

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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medical Class II
2023-12-27

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class II
2023-11-22

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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medical Class III
2022-03-16

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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medical Class II
2021-03-17

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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medical Class II
2020-06-17

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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medical Class II
2020-06-17

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 →