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Philips North America Recalls
530 recalls on record · April 5, 2017 to July 1, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
March 25, 2020Medical DevicesFDA
Philips North America, LLC recalls Integris Allura 9, system codes 722018 722021
Hazard: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
March 25, 2020Medical DevicesFDA
Philips North America, LLC recalls Integris Allura 15 & 12, monoplane (system code 722043) and biplane (system code 722044)
Hazard: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
March 25, 2020Medical DevicesFDA
Philips North America, LLC recalls Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 72
Hazard: A capacitor inside the converter of the Velara X-ray generator may fail after a large number of surges in a short period of time. When this occurs, no image acquisition is possible.
March 4, 2020Medical DevicesFDA
Philips North America, LLC recalls Philips DigiTrak XT Holter Recorder Software version number B.1 and C.2. The DigiTrak XT Recorder is available in four
Hazard: if an AAA battery is inserted in the recorder and a user attempts to start it, or if the recorder is inserted in the docking station, the recorder will display Error: 602 and fail to function for a new patient study.
March 4, 2020Medical DevicesFDA
Philips North America, LLC recalls Ambulance Parameter Extension (APE) kit M4758A, an accessory to the Philips HeartStart MRx Monitor/Defibrillator - Produ
Hazard: M4758A Ambulance Parameter Extension (APE) kit may cause ECG "Leads Off" condition in hot, humid environments
February 26, 2020Medical DevicesFDA
Philips North America LLC recalls Philips HeartStart HS1 Onsite (Model M5066A) and HSI Home (Model M5068A) AED, Model 861304, HSI codeRev: E.03.063
Hazard: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
February 26, 2020Medical DevicesFDA
Philips North America LLC recalls Philips HeartStart FRx AED, Model 861304, FRx codeRev: E.02.017
Hazard: Affected devices contain a Printed Circuit Assembly (PCA) that was not manufactured/repaired in accordance to quality standards.
February 19, 2020Medical DevicesFDA
Philips North America, LLC recalls VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper
Hazard: Due to a software defect, when a digital subtraction angiography (DSA) is exported to the VesselNavigator application, the DSA is displayed without subtraction.
December 11, 2019Medical DevicesFDA
Philips North America, LLC recalls HeartStart XL+ Defibrillator/Monitor, Model 861290
Hazard: Device may fail to turn on or unexpectedly attempt to restart, rendering it unable to return to a ready for use state. Additionally, this issue may occur when the device is in standby mode, when attempting to power on to run a self-test. If this occurs, the device will indicate that it is not ready for use.
November 27, 2019Medical DevicesFDA
Philips North America, LLC recalls HeartStart XL+ Defibrillator/Monitor, Model 861290
Hazard: The rotary therapy selector switch may fail, resulting in unexpected device behavior. These behaviors include: The device may not turn on; The device may not perform the selected function; The device may deliver a shock with an energy level different from the setting selected by the user.
October 2, 2019Medical DevicesFDA
Philips North America LLC recalls Philips HeartStart Infant/Child SMART Pads Cartridge, Model # M5072A, UDI:00884838023758
Hazard: The recall is being initiated due to incorrect age range labeling (8+ yrs) on the foil packaging for infant/child pad cartridges. The infant/child pad cartridge is designed for use with the defibrillator An Infant/Child pad cartridge should not be used on an adult because it delivers lower energy (50 J vs 150 J) than the Adult pads cartridge and may therefore not be effective on an adult.
September 25, 2019Medical DevicesFDA
Philips North America, LLC recalls IntelliVue 1.4 GHz Remote Antenna Used with Philips MX4O Monitors-The affected product is a 74 foot (22.6m) combined coa
Hazard: Remote Antenna Cable Used with Philips MX4O Monitors Does Not Have the Required Rating for Some Installations
September 18, 2019Medical DevicesFDA
Philips North America, LLC recalls Philips 5-Lead Set, Disposable, Bedside, AAMI Model # 989803173131 Product Usage: Philips Single-Patient-Use ECG le
Hazard: The thickness of the connector to the trunk cable on affected limb lead sets may be greater than specified. which may prevent or impede the performance of I 2-Lead ECG measurements.
September 18, 2019Medical DevicesFDA
Philips North America, LLC recalls HeartStart MRx Monitor/Defibrillator Model # M3535A - Product Usage: The HeartStart MRx is a lightweight, portable exte
Hazard: Non-conforming devices are identified, which may not have been included in prior field actions and may not have had a number of corrections applicable to these devices.
August 14, 2019Medical DevicesFDA
Philips North America, LLC recalls Philips Azurion systems with software version R1.2 -Interventional Fluoroscopic X-ray system as follows: Azurion 3 M
Hazard: The cold restart of Azurion R1.2 systems may take up to 7 minutes if the system is connected to the mains power supply for more than 50 days, may result in a delay of treatment.
July 17, 2019Medical DevicesFDA
Philips North America, LLC recalls Philips HeartStart MRx devices in use with the M3539A AC Power Module: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M
Hazard: The AC power module may fail at a higher than expected rate. If a fully charged battery is not properly installed, the HeartStart MRx may lose all power and fail to operate. Interruption of monitoring and failure or delay in the delivery of a shock or pacing can occur. A faulty AC Power Module may also fail to charge the battery.
June 19, 2019Medical DevicesFDA
Philips North America, LLC recalls Philips IntelliBridge System configured with a regional setting which uses a comma for a decimal separator: 866417 Int
Hazard: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values
June 19, 2019Medical DevicesFDA
Philips North America, LLC recalls Philips Patient Information Center iX configured with a regional setting which uses a comma for a decimal separator: 86
Hazard: Infusion Pump Data Storage Accuracy-Data from the BBraun Space LAN or Arcomed UniqueDoc infusion pumps transmitted via the HL7 output interface through the Patient Information Center iX using a LAN driver may be recorded in the patients chart or electronic medical record at exactly 100 times the actual bolus rate, infusion rate and total volume values
June 12, 2019Medical DevicesFDA
Philips North America, LLC recalls IntelliVue MX40 Patient Monitor, Product number 857146, Service Numbers All: 453564711531 and 453564711541 - Product Us
Hazard: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
June 12, 2019Medical DevicesFDA
Philips North America, LLC recalls IntelliVue MX40 Patient Monitor, Product number 865352, Service Numbers All: 453564262571, 453564262591, 453564615311, 4
Hazard: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
June 12, 2019Medical DevicesFDA
Philips North America, LLC recalls IntelliVue MX40 Patient Monitor, Product number 865351, Service Numbers All other countries: 453564451791, 453564451811
Hazard: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
June 12, 2019Medical DevicesFDA
Philips North America, LLC recalls IntelliVue MX40 Patient Monitor, Product number 865350, Service # USA: 453564262491 and 453564262511 - Product Usage: Us
Hazard: The MX40 may experience increased power consumption and may have a lack of visual and/or audible notifications while in a Low Battery State .
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS4 Government Bundle, Product Number 863286. For monitoring the physiological parameters of patients (NBP, S
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS4 NBP, SpO2, Product Number 863283. For monitoring the physiological parameters of patients (NBP, SpO2 & Te
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS3 NBP, SpO2, Rec, Product Number 863072. For monitoring the physiological parameters of patients (NBP, SpO2
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS3 NBP, SpO2, Product Number 863071. For monitoring the physiological parameters of patients (NBP, SpO2 & Te
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Tem
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
May 22, 2019Medical DevicesFDA
Philips North America, LLC recalls SureSigns VS3 NBP, Product Number 863069. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperat
Hazard: System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.