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.

76–100 of 160

  • HighFDA (Devices)·Z-2322-2017·2017-06-21

    Philips DuraDiagnost X-ray systems recalled for cracked welding joints

    Philips is recalling 98 DuraDiagnost X-ray systems because the tube arm assembly could fall due to cracked welding joints.

    Product
    Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-2528-2017·2017-06-21

    Philips M3150 Information Center Software Recalled for Component Failure

    Philips is recalling 607 M3150 Information Center units worldwide due to a potential for early component failure. The software is used to display physiologic data and alarms.

    Product
    M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to disp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2154-2017·2017-06-21

    Philips DigitalDiagnost 3.1.x X-Ray System Recalled for Performance Issues

    Philips is recalling DigitalDiagnost 3.1.x X-Ray Systems in the US due to a potential issue that may affect equipment performance under certain conditions.

    Product
    Philips DigitalDiagnost 3.1.x X-Ray System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2017·2017-06-07

    Philips NMT Patient Cable Recall for Potential Skin Burn Risk

    Philips is recalling NMT Patient Cables used with IntelliVue NMT Modules because a manufacturing defect may cause localized heating and skin burns.

    Product
    NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)
    Category
    Medical Device
    Distribution
    31 states
  • SevereFDA (Devices)·Z-1820-2017·2017-04-26

    Philips Recalls Allura Xper Systems Due to Chiller Leak Fire Risk

    Philips is recalling specific Allura Xper medical imaging systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    Allura Xper Release 8.2 (Laird chiller is always installed); Allura Xper FD10 722026; Allura Xper FD10/10 722027; Allura Xper FD20/10 biplane 722029; Allura Xper FD10 OR Table 722033; Allura Xper FD10/10 OR Table 722034; Allura Xper FD20/10 OR Table 722036; Allure Xper FD20/20 72
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1822-2017·2017-04-26

    Philips Allura Xper Systems Recalled for Chiller Leak Fire Risk

    Philips is recalling specific Allura Xper systems equipped with Laird chillers because a leak in the cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    The following systems are only affected if a Laird chiller is installed (11NC: 98960021599): Allura Xper Releases 3 to 8.1: Allura Xper FD10 (C+F). 722003; Allura Xper FD10/10 722005; Allura Xper FD20 722006; Allura Xper FD20/10 and FD20/20 722008; Allura Xper FD10 722010; All
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1821-2017·2017-04-26

    Philips UNIQ X-ray Systems Recalled for Potential Fire Hazard

    Philips is recalling UNIQ X-ray systems because a leak in the detector cooling system could cause liquid to drip onto electrical components, potentially leading to fire.

    Product
    UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1707-2017·2017-04-12

    Philips IntelliVue MX4O Monitor Recall for Alarm Failure

    Philips is recalling IntelliVue MX4O Patient Wearable Monitors that may fail to switch to Monitor Mode with audible alarms if the connection to the central system is lost.

    Product
    Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only, US only 453564615331 TELE PWM,802.1 1 a/b/g,ECG&Sp02, US only Product Usage: Indicated for use by health care professionals w
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1229-2017·2017-03-01

    Philips Efficia CMS200 Central Monitoring System Recalled for Pediatric Alarm Defect

    Philips is recalling 156 Efficia CMS200 central monitoring systems because they may not alarm appropriately for pediatric or neonatal patients.

    Product
    Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professionals for central viewing of physiologic waves, parameters, and trends from other networked medical devices (patient monitors and vital
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0924-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20 C-arm systems because production errors left screws loose, posing a risk of uncontrolled rotation.

    Product
    Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electrophysiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0923-2017·2017-02-01

    Philips Allura Xper FD10 X-ray System Recalled for Loose Screws

    Philips is recalling one Allura Xper FD10 X-ray system because production errors left screws loose, potentially causing the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0922-2017·2017-02-01

    Philips Allura Xper FD20 C-arm Recall for Loose Screws

    Philips is recalling one Allura Xper FD20 unit because production errors left screws loose, which could cause the C-arm to rotate uncontrolled.

    Product
    Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-0925-2017·2017-02-01

    Philips Allura Xper FD20/15 C-arm Recall Due to Loose Screws

    Philips is recalling two Allura Xper FD20/15 systems because production errors may cause C-arm screws to loosen, leading to uncontrolled rotation.

    Product
    Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and Electro Physiology(EP).
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1061-2017·2017-02-01

    Philips Recalls Velara Generators Due to Potential System Lockup

    Philips is recalling 59 Velara Generators used with Allura Xper Systems because the devices may lock up. The recall is voluntary and covers units in the US and internationally.

    Product
    Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura FD 10 F/C, Allura FD20, Allura XPER FD10/10, Allura XPER FD20 Biplane)
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1062-2017·2017-02-01

    Philips Velara Generator Recall for System Lockup Risk

    Philips is recalling 59 Velara Generators with old firmware used with the Integris BH5000 because the system may lock up.

    Product
    Velara Generator with an old Firmware version used with the Philips Integris BH5000
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-1106-2017·2017-02-01

    Philips Cisco 3850 Switch Recall Due to Monitoring Loss Risk

    Philips is recalling Cisco 3850 switches used with IntelliVue systems because they may experience a loss of centralized monitoring.

    Product
    Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
    Category
    Medical Device
    Distribution
    19 states
  • ModerateFDA (Devices)·Z-0825-2017·2016-12-28

    Philips Ingenia MR-OR Recalled for Potential Touch Current Exposure

    Philips is recalling nine Ingenia MR-OR units due to a possibility that patients or users may be exposed to a very small level of touch current.

    Product
    Ingenia MR-OR; 781437, 781438 The MR-OR option is intended for allowing transfer of a neurosurgical patient from OR suite to MR suite and back with tools and instructions for proper positioning and MR imaging of those patients. MR-OR option also facilitates execution of simple n
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0376-2017·2016-11-30

    Philips CT Scanner Recall Due to Potential Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0375-2017·2016-11-30

    Philips CT Scanner Recall Due to Tabletop Movement Failure

    Philips is recalling 1,363 CT scanners because the patient support tabletop may fail to move horizontally during scans due to a mechanical linkage failure.

    Product
    Philips Healthcare System X-ray Tomography Computed :
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recalled for ECG Alarm Configuration Issue

    Philips is recalling 2,212 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms. Users should contact Philips for a software update.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 453564262571 453564262591 4535646153
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling 1,824 IntelliVue MX40 patient monitors worldwide because a configuration setting may disable ECG alarms.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 Exchange part: 453564262531 453564262551 4535
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2017·2016-10-26

    Philips IntelliVue MX40 Patient Monitor Recall for ECG Alarm Configuration Issue

    Philips is recalling IntelliVue MX40 patient monitors because a configuration setting may disable ECG alarms. The issue affects 9,804 units distributed in the US and 35 other countries.

    Product
    Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564262511 453564615311 453564615331 453564262571 453564262591 USA only SW Revisions: B.05.28, B.05.29, and B.05.32 Indicated f
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2842-2016·2016-09-28

    Philips HeartStart MRx Monitor/Defibrillator Recall for Handle Separation

    Philips is recalling 394 HeartStart MRx Monitor/Defibrillators because the handle can separate from the housing due to broken mounts.

    Product
    HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2681-2016·2016-09-07

    Philips PCR Compano Basic Reader Recalled for Power Supply Fire Hazard

    Philips is recalling 388 PCR Compano Basic Reader units because a defective power supply component can burn and release smoke.

    Product
    PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-2669-2016·2016-09-07

    Philips Recalls Allura Xper Systems Due to Power Supply Failure Risk

    Philips is recalling 1,536 Allura Xper medical imaging systems because certain low-voltage DC power supplies have an increased failure rate.

    Product
    Allura Xper with release R8.2: Allura Xper FD10, 722026; Allura Xper FD10/10, 722027; Allura Xper FD20, 722028; Allura Xper FD20/10 biplane, 722029; Allura Xper FD10 OR Table, 722033; Allura Xper FD10/10 OR Table, 722034; Allura Xper FD20 OR Table, 722035; Allure Xper FD
    Category
    Medical Device
    Distribution
    Distributed nationwide