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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.
February 10, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper FD10/10; Model Numbers: 722027 722011 722005 Intended for Cardiovascular and vascular X-ray imaging appli
Hazard: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
February 10, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular
Hazard: The use of Allura Xper, Allura Clarity, Allura CV, Allura Centron and UNIQ systems regarding live images and still images can lead to still images being interpreted as live Images.
December 30, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Cardinal Health Tiny Toes; 11470-010T Infant heel warmer
Hazard: Heel warmers may cause first and second degree burns.
December 23, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare Ingenuity CT Computed Tomography X-ray system
Hazard: During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
December 23, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare Ingenuity Core 128 Computed Tomography X-ray system
Hazard: During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
December 23, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare Ingenuity Core Computed Tomography X-ray system
Hazard: During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
December 23, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare Brilliance 64 Computed Tomography X-ray system
Hazard: During scans with specific protocol steps, the software unexpectedly sets the Axial ( 2 axis ) scan length to a different length than the user set in the plan.
December 2, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M
Hazard: The following MRx software issue has been identified: MRx model M3535A with software version F.03.06 and earlier, and model M3536A with version T.00.05 and earlier may stop the automated Ready-For-Use (RFU) test in an abnormal state when the device is turned off.
November 25, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and
Hazard: When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.
September 2, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDia
Hazard: The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the Microsoft Windows 7 operating system.
August 12, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips HeartStart XL+ Defibrillator/Monitor Product Usage: The HeartStart XL+ is intended for use in a hospital set
Hazard: Multiple software and hardware issues with device that can affect its function.
August 5, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Invivo Expression MRI Patient Monitoring System.
Hazard: The device's labeling inaccurately indicates Endotracheal as a body temperature application site. The FlexTEMP reusable temperature sensor is not intended to be used for endotracheal placement. The application site should be listed as Esophageal.
July 29, 2015Medical DevicesFDA
Philips Electronics North America Corporation recalls Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931
Hazard: Philips, Pinnacle Radiation Treatment Planning System version 8.0h, 8.0k, 8.0m, 8.0n, 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl.