The Recall Desk

Manufacturer

Philips Medical Systems, Inc.

65 recalls in our database name Philips Medical Systems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
65
Critical
0
Severe
14
Most recent
2016-04-06

Of the 65 recalls from Philips Medical Systems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 14 (22%) 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.

1–25 of 65

  • ModerateFDA (Devices)·Z-1280-2016·2016-04-06

    Philips Medical Systems Recalls Foot Switches for Bent Pedal Defect

    Philips Medical Systems is recalling 4,180 foot switches used with Allura Xper systems because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with the following systems: Philips Allura Xper Systems; 722001 AlluraXperFDlO C, 722002 Allura Xper FD1O F, 722003 Allura Xper FD1O, 722005 Allura Xper FD1O/10, 722006 Allura Xper FD2O, 722008 Allura Xper FD2O Biplane, 722010 Allura Xper FD1O, 722011 Allura Xp
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1279-2016·2016-04-06

    Philips MultiDiagnost Eleva Foot Switches Recalled for Bent Pedal Defect

    Philips Medical Systems is recalling 168 foot switches used with the MultiDiagnost Eleva system because a bent pedal can cause loss of key image functionality.

    Product
    Foot Switches used with Philips MultiDiagnost Eleva with Flat Detector; Product Codes: 708037, 708038 This Philips MultiDiagnost Eleva is intended to be used as a multifunctional/universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0374-2016·2015-12-16

    Philips IntelliVue Information Center iX Software Recall for Alarm Failure

    Philips is recalling IntelliVue Information Center iX software because SpO2 and NBP alarms may disable without visual notification.

    Product
    Philips IntelliVue Information Center iX (release A.00, A.01, and A.02) are impacted by this issue: 866023 IntelliVue Info Center iX 866024 PIIC iX Upgrade 866117 PIIC Classic Upgrade The intended use of the Information Center Software is to display physiologic waves, param
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0354-2016·2015-12-09

    Philips Xper Vascular System Monitor Ceiling Suspension Recall

    Philips Medical Systems is recalling 22 Allura Xper vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0353-2016·2015-12-09

    Philips Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 14 Allura Xper Cardio systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper cardio systems R7.6 Model : 722133 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2016·2015-12-09

    Philips Allura Xper Cardio Systems Recalled for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 16 Allura Xper cardio systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper cardio systems Model : 722123 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and throm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0349-2016·2015-12-09

    Philips INTEGRIS Vascular System Recall for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling three INTEGRIS vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0346-2016·2015-12-09

    Philips Allura Xper Series Recall Due to Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling nine Allura Xper Series units because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Allura Xper Series: Allura Xper FD10 Allura Xper FD10/10 Allura Xper FD20 Allura Xper FD21 Allura Xper FD22 Allura Xper FD23 Allura Xper FD24 Allura Xper FD25 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0348-2016·2015-12-09

    Philips INTEGRIS Cardio System Ceiling Suspension Recall

    Philips is recalling eight INTEGRIS cardio systems because the ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS cardio system Model : 722121 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and th
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2016·2015-12-09

    Philips EasyDiagnost Patient Support Material Recalled for Footplate Safety Hazard

    Philips Medical Systems is recalling patient support materials for the EasyDiagnost device because the footplate hook may fail, causing the footplate to fall or swing and potentially injure patients or operators.

    Product
    Patient Support Material Number: 9890 010 87431, used with:EasyDiagnost ; Model: 706050
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0364-2016·2015-12-09

    Philips BuckyDiagnost Patient Support Material Recall for Footplate Safety

    Philips Medical Systems is recalling BuckyDiagnost patient support materials because the footplate hook may fail, causing the plate to fall or swing and injure patients or operators.

    Product
    Patient Support Material Number: 9890 010 87431 used with: BuckyDiagnost ; Model: 704060/706037
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0347-2016·2015-12-09

    Philips Allura BiPlane Ceiling Suspension System Recall for Fall Risk

    Philips Medical Systems is recalling five Allura BiPlane X-ray systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Allure BiPlane Series: Model 722013 Allura Xper FD20 BIPLANE R7.6 722013 Allura Xper FD20 BIPLANE R7.7 722013 Allura Xper FD20 BIPLANE R7.8 722013 Allura Xper FD20 BIPLANE R7.9 722013 Allura Xper FD20 BIPLANE R7.10 Product Usage: The Allur
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0352-2016·2015-12-09

    Philips Xper Vascular System Recall for Ceiling Suspension Fall Risk

    Philips Medical Systems is recalling 10 Xper vascular systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare Xper vascular system Model : 722124 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and thr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0350-2016·2015-12-09

    Philips Allura X-Ray System Ceiling Suspension Recall

    Philips Medical Systems is recalling INTEGRIS H5000F/Allura 9F X-ray systems because the monitor ceiling suspension system may fall.

    Product
    Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage: The Allura Xper series is intended for use in cardiovascular and vascular X-ray imaging applications including diagnostics, interventional procedures (such as PTCA, stent placement, embolization and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0325-2016·2015-12-02

    Philips MRI Systems Recalled for Reversed Image Order in MobiView Software

    Philips is recalling specific MRI systems with MobiView software due to a defect that reverses the order of fused multi-station scan images.

    Product
    Ingenia, Intera, Achieva and Achieve dStream MR systems on Software versions R5.1.7 and R5.1.8 with the Mobi View software option. Diagnostic imaging system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2016·2015-11-18

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Hardware Defects

    Philips is recalling HeartStart MRx Monitor/Defibrillators because the CO2 inlet port can become inaccessible or the handle can separate from the housing.

    Product
    Philips HeartStart MRx Monitor/Defibrillator Models:M3535A, M3536A, M3536M, M3536MC, M3536M4, M3536M5 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 o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0204-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillators Recalled for Capacitor Degradation

    Philips is recalling 1,553 HeartStart MRx Monitor/Defibrillators because automated tests may degrade capacitors and the low battery indicator may fail.

    Product
    Philips HeartStart MRx Monitor/Defibrillators Models: M3535A and M3536A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2016·2015-11-11

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Potential Reboot Issues

    Philips is recalling HeartStart MRx monitor/defibrillators because they may reboot unexpectedly, interrupting or delaying therapy.

    Product
    HeartStart MRx monitor/defibrillator Models M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualifie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0135-2016·2015-10-28

    Philips MRI Systems Recalled for Incorrect Cross-Reference Lines in Spine Imaging

    Philips Medical Systems is recalling specific MRI systems due to a software defect that may cause cross-reference lines to be positioned incorrectly in spine clinical workflows.

    Product
    All Philips Ingenia, Intera, Achieva and Multiva MR systems using R5.1i and R5.1 .2 version of software. Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head,
    Category
    Medical Device
    Distribution
    22 states
  • SevereFDA (Devices)·Z-1643-2015·2015-05-27

    Philips Pinnacle3 Software Recall Due to Incorrect Dose Calculation

    Philips Medical Systems is recalling Pinnacle3 software version 10.0 because a defect in the dose engine may cause incorrect radiation therapy dose calculations.

    Product
    Pinnacle3 Software Version 10.0, Model 459800200841. Product Usage: The Pinnacle 3 RTP software allows qualified medical professionals to enter patient data into the system, use that data to construct a plan for radiation therapy and evaluate the plan. Optionally, the qualif
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1555-2015·2015-05-27

    Philips DuraDiagnost X-Ray System Recalled for Missing Exposure Beep

    Philips Medical Systems is recalling DuraDiagnost X-ray systems because they may fail to emit a termination beep after 12 hours of operation, violating safety regulations.

    Product
    Philips Healthcare DuraDiagnost X- Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1554-2015·2015-05-27

    Philips DigitalDiagnost X-Ray System Recalled for Missing Exposure Beep Signal

    Philips Medical Systems is recalling 54 DigitalDiagnost X-Ray systems because they fail to emit a beep signal after exposure if powered on for over 12 hours.

    Product
    Philips Healthcare DigitalDiagnost System X-Ray
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1307-2015·2015-04-01

    Philips Recalls Lithium Polymer Fiber Optic Module Batteries Due to Ignition Risk

    Philips Medical Systems is recalling 79 lithium polymer fiber optic module batteries used in Intera MR Systems because a battery ignited during recharging.

    Product
    Lithium Polymer Fiber Optic Module Batteries used in the Intera MR System upgraded to CDAS, Part Number: 9065 and 9067. These rechargeable batteries are used to supply power to the following products: Wireless ECG Module used with the Precess MRI compatible Patient Monitoring S
    Category
    Medical Device
    Distribution
    20 states
  • SevereFDA (Devices)·Z-1251-2015·2015-03-18

    Philips DuraDiagnost X-Ray System Recalled for Installation Defects

    Philips Medical Systems is recalling 71 DuraDiagnost X-Ray systems worldwide due to improper installation risks that could cause equipment to fall or float.

    Product
    Philips DuraDiagnost X-Ray system, Stationary X-Ray System Radiographic Models: 712210, 712211
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1120-2015·2015-03-11

    Philips Allura Xper X-Ray Angiographic Software Recall

    Philips Medical Systems is recalling Allura Xper X-Ray Angiographic systems due to a software error that may prevent the five-minute fluoroscopy audible signal from sounding.

    Product
    Philips Medical System Allura Xper X-Ray Angiographic
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Philips Medical Systems

company based in Hamburg, Germany

Country
Germany
Founded
1987
Parent company
Philips (Germany)

Official website

Source: Wikidata (Q2087959), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.