The Recall Desk

Manufacturer

Philips Electronics North America Corporation

160 recalls in our database name Philips Electronics North America Corporation as the manufacturing or recalling firm.

What the numbers show

Total
160
Critical
0
Severe
19
Most recent
2018-12-26

Of the 160 recalls from Philips Electronics North America Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (12%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 160

  • HighFDA (Devices)·Z-2670-2016·2016-09-07

    Philips Recalls UNIQ 1.0 Fluoroscopy Systems Due to Power Supply Failures

    Philips is recalling 1,536 UNIQ 1.0 fluoroscopy systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table, 722034; UNIQ FD20 OR Table, 722035; UNIQ FD20/20, 722038; UNIQ FD20/20 biplane OR Table, 722039; UNIQ FD20/15, 722058; UNIQ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2307-2016·2016-08-10

    Philips MultiDiagnost Eleva X-Ray System Recalled for Bolt Failure Risk

    Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts may break, causing the C-arm to sag. The recall covers units distributed worldwide.

    Product
    MultiDiagnost Eleva; x-ray system. Product Codes: 708032, 708036
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2328-2016·2016-08-10

    Philips IntelliVue Patient Monitor Recall for Outdated Waveform Data

    Philips is recalling IntelliVue Patient Monitors because they may display outdated waveform data if powered on continuously for several months, failing to reflect current patient conditions.

    Product
    IntelliVue Patient Monitor Product Usage: The monitors are indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The monitors are intended to be used for monitoring and recording of, and to generate al
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2305-2016·2016-08-10

    Philips MultiDiagnost Eleva X-Ray System Recalled for Potential Bolt Failure

    Philips is recalling 993 MultiDiagnost Eleva x-ray systems because bolts attaching the clamping plate may break, causing the C-arm to sag.

    Product
    MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1612-2016·2016-05-11

    Philips HeartStart MRx Monitor/Defibrillator Recall for Charging Failure

    Philips is recalling 17 HeartStart MRx Monitor/Defibrillators because a faulty circuit board may prevent the device from charging.

    Product
    HeartStart MRx Monitor/Defibrillator The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life sup
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1316-2016·2016-04-13

    Recall of eValueMed Infant Heel Warmers and Transport Mattresses

    Philips is recalling eValueMed Infant Heel Warmers and Transport Mattresses because they lack expiration dates and warnings about overheating risks after shelf life.

    Product
    evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1317-2016·2016-04-13

    Philips Recalls eValueMed Infant Heel Warmers and Transport Mattresses

    Philips is recalling eValueMed infant heel warmers and transport mattresses because they lack expiration dates and warnings about overheating risks.

    Product
    eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for use when circulation needs to be stimulated in the infant heel in order for blood sampling to occur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1066-2016·2016-03-16

    Philips Allura Xper X-Ray Systems Recalled for Fluoroscopy Failure

    Philips is recalling 196 Allura Xper X-ray systems because they may display a 'Fluoro failed' error message when initiating fluoroscopy.

    Product
    Philips X-Ray Systems, Allura Xper with R8.2.16 Product Usage: The Allura Xper FD1O and Allura Xper FD1O/10 is intended for use in cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and athere
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1024-2016·2016-03-09

    Philips SENSE Body Coil 1.5T Recalled for Potential Patient Burns

    Philips is recalling 5,672 SENSE Body Coil 1.5T units because improper cable placement can cause patient burns during MRI scans.

    Product
    SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0853-2016·2016-03-02

    Philips IntelliVue Measurement Module X1 Recalled for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Measurement Module X1 units because the ST elevation alarm may not sound for specific ECG leads.

    Product
    Philips IntelliVue Measurement Module X1 Model: M3001A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0854-2016·2016-03-02

    Philips IntelliVue Module Measurement X2 Recall for ST Alarm Failure

    Philips is recalling 13,300 IntelliVue Module Measurement X2 units because the ST elevation alarm may not sound during Hexad 12-Lead ECG monitoring.

    Product
    Philips IntelliVue Module Measurement X2 Model: M3002A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0858-2016·2016-03-02

    Philips IntelliVue Info Center iX Recalled for ECG Waveform Misrepresentation

    Philips is recalling IntelliVue Info Center iX monitors because reconstructed ECG leads may misrepresent waveforms, potentially affecting clinical interpretation.

    Product
    Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0857-2016·2016-03-02

    Philips PIIC Classic Upgrade Patient Monitor Recall for ECG Waveform Misrepresentation

    Philips is recalling PIIC Classic Upgrade patient monitors because reconstructed ECG leads may misrepresent waveforms on the Information Center iX.

    Product
    Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0810-2016·2016-02-24

    Philips recalls actuator assemblies for angiographic x-ray monitor ceiling suspension systems

    Philips is recalling actuator assemblies for angiographic x-ray monitor ceiling suspension systems because the actuator can detach, causing the monitor carriage to drop.

    Product
    Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0765-2016·2016-02-17

    Philips Allura Xper FD OR Table Recalled for C-Arc Movement Issue

    Philips is recalling two Allura Xper FD OR Tables because the C-arc may continue moving after stopping due to improper adjustment.

    Product
    Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0766-2016·2016-02-17

    Philips TraumaDiagnost X-ray Units Recalled for Arm Fall Hazard

    Philips is recalling TraumaDiagnost radiological examination units because the arm may not be fastened securely and could fall down.

    Product
    Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-0764-2016·2016-02-17

    Philips Allura Xper FD20 Ceiling Version Recalled for C-Arc Movement

    Philips is recalling 15 Allura Xper FD20 Ceiling version units because improper adjustment may cause the C-arc to continue moving after stopping.

    Product
    Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0709-2016·2016-02-10

    Philips UNIQ and Allura Systems Recall for Image Interpretation Error

    Philips is recalling UNIQ and Allura systems because a software issue may cause still images to be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD OR table; Model Number 722035 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0725-2016·2016-02-10

    Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.

    Product
    INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0715-2016·2016-02-10

    Philips Allura Medical Imaging Systems Recalled for Image Interpretation Error

    Philips is recalling Allura CV20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.

    Product
    Allura CV20; Model Number: 722031 The Allura CV2O is intended for physicians (e.g. cardiologists and radiologists), assisted by trained hospital staff (e.g. nurses and lab technicians), who are qualified to perform medical procedures on humans (having a maximum weight of 250 k
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0708-2016·2016-02-10

    Philips UNIQ and Allura Systems Recalled for Image Interpretation Error

    Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.

    Product
    UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0712-2016·2016-02-10

    Philips Allura Xper Biplane OR Table Recall for Image Interpretation Error

    Philips is recalling Allura Xper FD20 Biplane OR Tables because still images may be incorrectly interpreted as live images during use.

    Product
    Allura Xper FD20 Biplane OR Table; Model Numbers: 722025 722020 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent
    Category
    Medical Device
    Distribution
    Distributed nationwide