The Recall Desk

Manufacturer

Philips Healthcare Inc.

36 recalls in our database name Philips Healthcare Inc. as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
0
Severe
6
Most recent
2017-04-12

Of the 36 recalls from Philips Healthcare Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 6 (17%) 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 36

  • ModerateFDA (Devices)·Z-1706-2017·2017-04-12

    Philips Recalls Mobile Diagnostic X-Ray Systems Due to Marker Placement Error

    Philips Healthcare Inc. is recalling 220 Mobile Diagnostic X-Ray Systems because electronic markers may be placed at the wrong anatomical position when images are moved between views.

    Product
    Mobile Diagnostic X-Ray System with Digital Panel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1783-2014·2014-06-18

    Philips IntellVue Info Center Patient Monitor Recall for Reboot Loop

    Philips is recalling IntellVue Info Center monitors because a software defect causes reboot loops that interrupt patient monitoring.

    Product
    Philips IntellVue Info Center iX 866023; PIIC iX Upgrade 866024; IntellVue Server iX Upgrade 866026; PIIC Classic Upgrade 866117 Patient Physiological Monitor.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2059-2013·2013-09-04

    Philips Easy Upgrade DR Recalled for Potential Image Marker Misinterpretation

    Philips Healthcare is recalling 89 Easy Upgrade DR systems because a mirror icon on images could be misinterpreted as a right lead marker if the image is mirrored in a PACS system.

    Product
    Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1964-2013·2013-08-28

    Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use

    Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.

    Product
    Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1797-2013·2013-07-31

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Incorrect Therapy Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may deliver non-synchronized cardioversion shocks, potentially inducing ventricular fibrillation.

    Product
    Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1780-2013·2013-07-31

    Philips IntelliVue Smart-hopping 1.4 GHz Access Point Recalled for Signal Loss

    Philips Healthcare is recalling IntelliVue Smart-hopping 1.4 GHz Access Points due to unexpected signal loss that impacts wireless connectivity.

    Product
    Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips Inte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1450-2013·2013-06-26

    Philips BuckyDiagnost Radiographic Systems Recalled for Table Height Defects

    Philips Healthcare is recalling 116 BuckyDiagnost radiographic systems because table height measurements were found out of specification, potentially causing system mis-alignment.

    Product
    Philips BuckyDiagnost Radiographic. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1449-2013·2013-06-26

    Philips BuckyDiagnost Radiographic X-ray System Recalled for Documentation Issues

    Philips Healthcare Inc. is recalling 66 BuckyDiagnost Radiographic X-ray systems because installation acceptance test documentation was missing or inconsistent.

    Product
    Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system. Catalog Numbers: 704031, 704032, 704035, 704060, 704062 This system is used for making x-ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1448-2013·2013-06-26

    Philips Diagnost Stationary Radiographic System Recalled for Table Height Non-Compliance

    Philips Healthcare Inc. is recalling 101 units of Diagnost Stationary Radiographic Systems because installation records show table height measurements out of specification.

    Product
    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1447-2013·2013-06-26

    Philips Radiographic Systems Recalled for Non-Compliant Installation Test Documents

    Philips Healthcare is recalling 177 stationary radiographic systems because their Installation Acceptance Test Documents were non-compliant with regulations or could not be located.

    Product
    Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1189-2013·2013-05-08

    Philips HeartStart MRx Monitor/Defibrillator Recalled for Therapy Failure Risk

    Philips is recalling HeartStart MRx Monitor/Defibrillators because they may fail to deliver defibrillation therapy in Manual Defib or AED mode.

    Product
    HeartStart MRx Monitor/Defribillator; Product Codes: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1003-2013·2013-04-24

    Philips Healthcare Recalls CT Systems Due to Inaccurate Dose Measurements

    Philips Healthcare is recalling CT systems because CTDI measurements were 15 to 25% higher than protocol parameters.

    Product
    Philips Healthcare Computed Tomography X-Ray System. These devices are whole-body computed tomography (CT) x-ray systems or sub-systems, each with a continuously rotating x-ray tube and multi-row detectors enclosed by a gantry. X-ray transmission data acquired and taken at
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0884-2013·2013-03-06

    Philips DigitalDiagnost X-Ray System Recalled for Image Rotation Errors

    Philips Healthcare Inc. is recalling 551 DigitalDiagnost X-Ray Systems because images may rotate in the wrong direction, causing electronic side markers to be placed incorrectly.

    Product
    Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0871-2013·2013-02-27

    Philips HeartStart XL+ Defibrillators Recalled for Potential Lockout

    Philips is recalling 3,785 HeartStart XL+ defibrillators because they may become locked out of clinical use.

    Product
    Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced life support or defi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0824-2013·2013-02-20

    Philips SureSigns VS2+ Vital Signs Monitor Recall for Screen Lockup

    Philips Healthcare is recalling 3,248 SureSigns VS2+ monitors because the screen may lock up and stop monitoring patients.

    Product
    Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Usage: The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0767-2013·2013-02-13

    Philips Easy Diagnost Eleva DRF Recalled for Image Marker Misinterpretation

    Philips Healthcare is recalling 14 Easy Diagnost Eleva DRF units because a mirror icon on images could be misinterpreted as a right lead marker in PACS systems.

    Product
    Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0702-2013·2013-02-06

    Philips Juno DRF X-ray System Recalled for Display Compliance Issues

    Philips Healthcare is recalling 16 Juno DRF X-ray systems because fluoroscopy dose values may not display correctly at the operator's position.

    Product
    Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0495-2013·2012-12-19

    Philips IntelliVue Information Center Recall for Audible Alarm Loss

    Philips Healthcare is recalling IntelliVue Information Center software due to a potential loss of audible alarms caused by damaged internal audio cable contacts.

    Product
    Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Software is to display physiologic waves, parameters, and trends, format data for strip chart recordings and printed reports, and provide the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0475-2013·2012-12-12

    Philips Digital Diagnost Software Recall for Image Marker Error

    Philips is recalling Digital Diagnost Software R2.0.2 because a mirrored image marker can be mistaken for a patient side indicator.

    Product
    Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0011-2013·2012-10-10

    Philips HeartStart XL Defibrillators Recalled for Battery Failure Risk

    Philips is recalling HeartStart XL Defibrillators used with specific M3516A batteries that may fail without warning, potentially causing the device to shut down unexpectedly during use.

    Product
    Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully featured, defibrillator intended for use by qualified medical personnel, trained in either Advanced Cardiac Life Support or in the operation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2494-2012·2012-10-10

    Philips Digital Diagnost Patient Carriage Footplate Recall

    Philips is recalling Digital Diagnost patient carriages because the footplate hook may fail, causing the footplate to fall on patients or operators.

    Product
    Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543. Product Usage: Stationary radiographic System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2465-2012·2012-10-03

    Philips Digital Diagnost Mobile Detector Holder Recall for Insecure Fit

    Philips is recalling 93 Mobile Detector Holders because the Wireless Portable Detector may not be fixed securely and could fall down.

    Product
    Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2384-2012·2012-09-26

    Philips DigitalDiagnost Systems Recalled for Electrical Safety Standard Non-Compliance

    Philips Healthcare Inc. is recalling four DigitalDiagnost Systems because the GEO Transformer does not meet international electrical safety standards.

    Product
    Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-2347-2012·2012-09-19

    Philips HeartStart MRx Monitor Defibrillators Recalled for Cable Wear

    Philips is recalling HeartStart MRx monitor/defibrillators because wear on the therapy cable connection may cause the device to fail to detect defibrillation pads or paddles.

    Product
    Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536M5, M3536M6 The Heartstart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for
    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 Healthcare

Division of Philips manufacturing healthcare equipment and providing related services

Source: Wikidata (Q4046835), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.