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Philips Electronics North America Recalls
163 recalls on record · July 29, 2015 to December 26, 2018 · 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.
August 29, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips SureSigns VS2 monitor, 863079 863080 863081 863082 863283 863286 The Sure Signs VS2 vital signs monitor
Hazard: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
August 29, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips SureSigns VM 3/4/6/8 Patient Monitors, 863063 863064 863065 863066 863068 863077 863085 863086 863317 8
Hazard: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
August 29, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips SureSigns VS4 Vital Signs Monitor, 863283 863286 The SureSigns VS4 vital signs monitor is for use by health
Hazard: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
August 29, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips SureSigns VS3 Vital Signs Monitor, 863069 863070 863071 863072 863073 863074 The SureSigns VS3 monitor i
Hazard: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
August 29, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and
Hazard: Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300 charge-discharge cycles. Although the Philips SureSigns VS & VM Monitors and View Station (VSV) can display actual information on either or both battery age and charge-discharge cycles, the existing labeling does not include full instructions on how to use this information to determine when to replace the battery. An overheated battery may in turn cause the device case to overheat and possibly melt or cause the device to ignite, which can cause injury to a patient, nearby users, or cause damage to property.
June 20, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 867146
Hazard: Five warning statements are missing from the instructions for use.
June 20, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865352
Hazard: Five warning statements are missing from the instructions for use.
June 20, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865351
Hazard: Five warning statements are missing from the instructions for use.
June 20, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350
Hazard: Five warning statements are missing from the instructions for use.
June 6, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrill
Hazard: The MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component. Failure to charge could potentially cause therapy to be interrupted or delayed.
May 30, 2018Medical DevicesFDA
Philips Electronics North America Corp. recalls Philips HeartStart (HS1) Onsite/Home AED
Hazard: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
May 30, 2018Medical DevicesFDA
Philips Electronics North America Corp. recalls Philips HeartStart FRx AED.
Hazard: An issue with one of the electric components (a resistor) could result in the device not delivering a shock when needed.
May 9, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray
Hazard: After continuous operation for more than one and a half days, the image on the large screen monitor may freeze for approximately 15 seconds after which the system will restore itself.
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spec
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Multiva systems; 1) Magnets Multiva 16 Model 781487, 2) Magnets 8 Model 781488, 3) Magnet Achieva 1.5T, Model 781492, 4)
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls T10-NT, Model 78107 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images,
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images,
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls T5-NT, Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, s
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Ingenia 1.5T CX, Models 781261 & 781262 Product Usage: Indicated for use as a diagnostic device. It can produce cros
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Conversion SmarthPath to dStream for 1.5T, Model 781260 Product Usage: Indicated for use as a diagnostic device. It
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Achieva 1.5T: 1) Nova (Dual), Model 781173, 2) Achieva 1.5T Initial Systems Model 781178, 3) Achieva 1.5T Nova Model 781
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Panorama 1.0T, Model 781250 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/N
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Intera 1.0T; 1) Stellar Model 781102, 2) Pular Model 781103 Product Usage: Indicated for use as a diagnostic device
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Intera 0.5T Standard, Model 781101 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sec
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 25, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Mod
Hazard: Potential risk for helium gas inside the MR examination room during a magnet quench
April 18, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls IntelliVue X3 Patient Monitor.
Hazard: The NBP measurement of Intellivue X3 Patient Monitor shows intermittently only mean values instead of the diastolic and systolic blood pressure values. This is caused by a falsely detected NBP cuff, which is leading to wrong internal NBP setting. Furthermore, occasionally the Monitor shows the Check Touch Input message and the monitor is inoperable with the touch interface.
March 21, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medica
Hazard: Update XL¿ device software to version A.03. This includes enhancements to the Operational Checks, event logs, and troubleshooting messages that provide as complete of information as needed to users on device readiness.
March 14, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Network Firewall (Cisco ASA 5506), Model # 867098
Hazard: Firewall installed with Philips IntelliVue Information Center iX or Information Center Classic may have a defective component, which may result in loss of connection to the Information Center iX. The defect involves the clock signal component within the firewall. This component has a high probability of failing in appliances that have been running for greater than 18 months. If the clock signal component were to fail, the firewall will stop functioning, will not boot, and is not recoverable. This failure will result in loss of communication between devices that are separated by the firewall, which may cause the Information Center to reboot.
March 7, 2018Medical DevicesFDA
Philips Electronics North America Corporation recalls Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center
Hazard: Once a surveillance station is restarted on January 1, 2018 or later, the station will be unable to perform patient discharge and transfer operations. Any subsequent attempt to perform these operations will cause the station to restart, resulting in a short period of loss of monitoring at the Surveillance station during such restart. Until this issue can be corrected, users should avoid intentionally restarting their Surveillance stations in 2018.