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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 1, 2017Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagn
Hazard: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
February 1, 2017Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnost
Hazard: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
February 1, 2017Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, i
Hazard: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
February 1, 2017Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, i
Hazard: Due to a production error, screws were not tightened to specified torque. These screws may come loose from the C-arm shaft causing the C-arm to rotate uncontrolled.
December 28, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR sui
Hazard: Possibility that a patient or user may be exposed to a very small level of touch current.
November 30, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare System X-ray Tomography Computed :
Hazard: It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
November 30, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare System X-ray Tomography Computed :
Hazard: It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.
October 26, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 45356426
Hazard: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
October 26, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Exce
Hazard: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
October 26, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchang
Hazard: Philips IntelliVue MX40 Patient Wearable Monitor Configuration Setting Disables Generation and Delivery of ECG Alarms to PIIC iX
September 28, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
Hazard: The handle can separate from the MRx housing due to breakage of mounts on the rear case.
September 7, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips DuraDiagnost stationary X-ray system
Hazard: Buttons or keys on the monitor allow the user to turn the volume setting down to 0", in which case the beep will not be heard at the conclusion of an exposure, as required 21 CFR 1020.31(j), and the Height-Adjustable Tabletop is missing the required labels [21 CFR 1010.2., 21 CFR 1010.3(a), and 21 CFR 1020.30(3)].
September 7, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological
Hazard: A defect component of the Compano reader power supply can cause the power supply to burn and some smoke to leave the housing.
September 7, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table,
Hazard: Increase in the failure rate of certain low-voltage DC power supplies (DCPS)
September 7, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allur
Hazard: Increase in the failure rate of certain low-voltage DC power supplies ( DCPS )
August 10, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever t
Hazard: If an affected Patient Monitor has been powered on continuously for several months, any displayed waveforms will contain outdated data and therefore fail to reflect the patients current condition.
August 10, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
Hazard: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
August 10, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls UroDiagnost; x-ray system. Product Code: 708033
Hazard: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
August 10, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
Hazard: The two bolts that attach the clamping plate to the lateral shaft may break, which could cause the c-arm to move laterally forward, slide out of its bearings, and sag
May 11, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and v
Hazard: MRx monitor/defibrillators could fail to charge because the therapy printed circuit board may have been loaded with an incorrect electronic component.
April 13, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulatio
Hazard: eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
April 13, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs
Hazard: eValueMed Infant Heel Warmers and eValueMed Infant Transport Mattresses bear no expiration date, nor any warning that product used beyond its expected shelf life may warm to temperature above its specification.
March 16, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is inten
Hazard: Upon initiating Fluoroscopy the user may encounter a user message Fluoro failed.
March 9, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
Hazard: Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.
March 2, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection o
Hazard: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
March 2, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
Hazard: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
March 2, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips Healthcare IntelliVue Info Center iX, A.0 866023
Hazard: Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads.
March 2, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips IntelliVue Module Measurement X2 Model: M3002A
Hazard: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
March 2, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Philips IntelliVue Measurement Module X1 Model: M3001A
Hazard: The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor
February 24, 2016Medical DevicesFDA
Philips Electronics North America Corporation recalls Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long
Hazard: The actuator assembly became detached and the monitor carriage with a flexvision monitor dropped to its lowest position.