Philips Healthcare recalls
Philips Healthcare appears in 57 official U.S. recall notices indexed by RecallRadar, most recently on 2023-10-11.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 57 |
|---|---|
| Published | 2012-06-20 to 2023-10-11 |
| By agency | FDA Device (57) |
| By classification | Class II (57) |
| By status | terminated (51), ongoing (5), completed (1) |
| Distribution named in notices | AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, US, VA, VT, WA, WI |
Recalls
- Incisive CT, software version 5.0
FDA Device · Class II · 2023-10-11 · Philips Healthcare
Reason: Philips has identified three software issues with compliance concerns to Subchapter J: Issue 1: Coronary Computed Tomography Angiography (CTA) scan may not be triggered at the optimal time. Issue 2: Use of aborted survi… - Philips StentBoost Live R2.0 application, when used with the Philips Azurion with software release R2.x
FDA Device · Class II · 2022-04-13 · Philips Healthcare
Reason: Due to an incorrect configuration setting in the EPX database of StentBoost Live, acquisition does not stop automatically as it should. When the user selects the StentBoost Live protocol on the Philips Azurion system, t… - Azurion systems with software release R2.0.x
FDA Device · Class II · 2022-03-30 · Philips Healthcare
Reason: In the Azurion system, the user can add a new study to a patient by selecting the option "Add Study". The Add Study dialogue box is then displayed where the Patient Type is selected to perform the study. Due to a softwa… - CombiDiagnost R90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare
Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and th… - Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Device · Class II · 2021-12-01 · Philips Healthcare
Reason: 3D-RA is a reconstruction software product that can be used with the Philips Azurin system. This product extends the functionality of compatible X-ray equipment with the capability of 3D X-ray imaging. Before starting a… - ProxiDiagnost N90 is multi-functional general R/F systems
FDA Device · Class II · 2021-12-01 · Philips Healthcare
Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and th… - DigitalDiagnost C90
FDA Device · Class II · 2021-12-01 · Philips Healthcare
Reason: The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and th… - DigitalDiagnost C50, Stationary X-ray System
FDA Device · Class II · 2019-10-02 · Philips Healthcare
Reason: During recent evaluations of the Philips DigitalDiagnost C50 system, Philips identified a missing label. This notification is intended to provide you with information regarding what the issue is, and relevant affected p… - UNIQ Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally invas…
FDA Device · Class II · 2018-08-01 · Philips Healthcare
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the exa… - Centron Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimally in…
FDA Device · Class II · 2018-08-01 · Philips Healthcare
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the exa… - Allura Xper Product Usage: Vascular,cardiovascular and neurovascular imaging applications,including diagnostic, interventional and minimall…
FDA Device · Class II · 2018-08-01 · Philips Healthcare
Reason: The first time an operator selects a new procedure type during a single examination,the shutter position resets to the open position for the new procedure type. If the shutters had previously been changed during the exa… - Mobile Diagnostic X-Ray System with Digital Panel
FDA Device · Class II · 2017-04-12 · Philips Healthcare
Reason: When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image. - Philips Healthcare Ingenuity Core128 Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips Healthcare Brilliance iCT Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips Healthcare Brilliance iCT SP Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips Healthcare Brilliance 64 Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips Healthcare DigitalDiagnost stationary X-ray system
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. - Philips Healthcare Ingenuity CT Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips Healthcare DuraDiagnost stationary X-ray system
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. - Philips Healthcare Ingenuity Core Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips Healthcare Ingenuity Elite Computed Tomography X-Ray System
FDA Device · Class II · 2016-06-15 · Philips Healthcare
Reason: Software Defects resulting in: (1) sagittal result shortened for axial scans; (2) single series displayed on console viewer when Creating multi-planner reconstruction; (3) scan length changes with a change in field of v… - Philips IntellVue Info Center iX 866023
FDA Device · Class II · 2014-06-18 · Philips Healthcare
Reason: If a customer creates customized trend scales in the trend review tile and the iX or primary server reboots for any reason, the iX(s) will enter a reboot loop. If one iX reboots, the issue will impact only those patient… - InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regula…
FDA Device · Class II · 2014-02-05 · Philips Healthcare
Reason: Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low patient temperature reading and low temperature alarm. - Philips Easy Upgrade DR, Code No: 712086 This system is used for making X-Ray exposures for diagnostics
FDA Device · Class II · 2013-09-04 · Philips Healthcare
Reason: The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. - Philips Healthcare MobileDiagnostwDR system
FDA Device · Class II · 2013-08-28 · Philips Healthcare
Reason: The Instructions for Use (IFU) for the MobileDiagnost wDR fails to comply with a Federal standard. The IFU does not provide tolerance levels for several generator values as required by 1020.30(h)(3). - Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: Intelli…
FDA Device · Class II · 2013-07-31 · Philips Healthcare
Reason: IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity - Philips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The…
FDA Device · Class II · 2013-07-31 · Philips Healthcare
Reason: The MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation. - Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD…
FDA Device · Class II · 2013-06-26 · Philips Healthcare
Reason: Installation Acceptance Test Document (IATD) non compliant with regulations. Records shows table height measurements out of specification with the consequence of potential system mis-alignment. - Philips BuckyDiagnost Radiographic, a Diagnostic X-ray system
FDA Device · Class II · 2013-06-26 · Philips Healthcare
Reason: An inspection shows several IATDs (Installation Acceptance Test could not be located or different templates have been used - Philips BuckyDiagnost Radiographic
FDA Device · Class II · 2013-06-26 · Philips Healthcare
Reason: An inspection of IATD (Installation Acceptance Test Document)IA SID (Source Image Distance) records shows table height measurements out of specification with the consequence of potential system mis-alignment - Philips Diagnost Stationary Radiographic System Models: 712020, 712022, 712050, 712052, 712055, 712057, 712062 Product Usage: Universal RAD…
FDA Device · Class II · 2013-06-26 · Philips Healthcare
Reason: Installation Acceptance Test Document (IATD) non compliant with regulations IATDs (Installation Acceptance Test could not be located or different templates have been used - HeartStart MRx Monitor/Defribillator
FDA Device · Class II · 2013-05-08 · Philips Healthcare
Reason: Device may fail to deliver defibrillation therapy in either Manual Defib or AED mode. - Philips Healthcare Computed Tomography X-Ray System
FDA Device · Class II · 2013-04-24 · Philips Healthcare
Reason: Philips Healthcare discovered the customer was performing CTDI measurements for facility accreditation and received results that were 15 to 25% higher than Philips protocol parameters stated. - Philips Digital Diagnost Stationary radiographic system
FDA Device · Class II · 2013-03-13 · Philips Healthcare
Reason: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. W… - Philips DigitalDiagnost X-Ray System with Eleva Software 2.1.3 Model numbers 712020, 712022, and 712082 Product Usage: Digital radiographic…
FDA Device · Class II · 2013-03-06 · Philips Healthcare
Reason: When the operator for a wall stand view selects an "image rotation" different from default, or such image rotation is preset in the examination database, then the resulting image may be rotated in the wrong direction. W… - Philips HeartStart XL+ Defibrillator/Monitor Model number: 861290 The HeartStart XL+ is intended for use in a hospital setting by qualified…
FDA Device · Class II · 2013-02-27 · Philips Healthcare
Reason: Philips HeartStart XL+ Defibrillator/Monitor may become locked out of clinical use - Philips Healthcare SureSigns VS2+ Model 863278 SureSigns VS2+ NBP and SpO2 Model 863279 SureSigns VS2+ NBP, SpO2 and Temperature Product Us…
FDA Device · Class II · 2013-02-20 · Philips Healthcare
Reason: VS2+ screen may lock up and stop monitoring during patient use - Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications
FDA Device · Class II · 2013-02-13 · Philips Healthcare
Reason: The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. - Juno DRF , X-ray system, diagnostic, Fluoroscopic, general-purpose Model: 70920 Product Usage: Universal R/F, general use
FDA Device · Class II · 2013-02-06 · Philips Healthcare
Reason: Values of fluoroscopy time, Air Kerma Rate and Cumulated Air Kerma may not be displayed "at the fluoroscopist's working position" as per 21 CFR 1003.21 - Philips IntelliVue Information Center/Client and Philips IntelliVue Information Center iX The intended use of the Information Center Softwa…
FDA Device · Class II · 2012-12-19 · Philips Healthcare
Reason: Internal audio cable may have diminished retention force due to damaged contacts, which could lead to intermittent or loss of audible alarms. - Philips Digital Diagnost Software Version R2.0.2 Product Usage: This system is used for making X-ray exposures for diagnostics
FDA Device · Class II · 2012-12-12 · Philips Healthcare
Reason: With Digital Diagnost R2.0.2 a mirrored "R in a circle" is burnt into the image (if mirrored) in the lower right corner of the image. When such an image is mirrored back inside the PACS system, an unmirrored "R in a cir… - Philips Digital Diagnost with patient carriage Model: 712050 with serial number range from 00 000 00 to 09 000 543
FDA Device · Class II · 2012-10-10 · Philips Healthcare
Reason: Hook does not securely hold the footplate in vertical position, causing the footplate to disengage and may fall on patient or operator - Philips HeartStart XL M4735A Defibrillator/Monitors, used with the M3516A batteries The Heart Start XL Defibrillator/Monitor is a fully fea…
FDA Device · Class II · 2012-10-10 · Philips Healthcare
Reason: HeartStart XL Defibrillator/Monitor (M4735A) used on a patient when AC power is not in use, with a battery that may fail, the device may shut down unexpectedly without providing the user with a low battery warning messa… - Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 7120…
FDA Device · Class II · 2012-10-03 · Philips Healthcare
Reason: The Wireless Portable Detector (WPD) is not fixed securely inside the Mobile Detector Holder and may fall down - Philips DigitalDiagnost Systems with M Cabinet Model: 712025 Stationary radiographic system, digital-Universal RAD Applications
FDA Device · Class II · 2012-09-26 · Philips Healthcare
Reason: Creepage Distance between the two primary phases in the GEO Transformer is 4.5 mm.does not meet (IEC) International standard of 5.5 mm. - Philips HeartStart MRx monitor/defibrillators Models: M3535A and M3536A, M3536J, M3536M, M3536MC, M3536M1, M3536M2, M3536M3, M3536M4, M3536…
FDA Device · Class II · 2012-09-19 · Philips Healthcare
Reason: Therapy Cable Connection wear may lead to a malfunction in detection of defibrillation pads/paddles therapy Cables - Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279
FDA Device · Class II · 2012-09-05 · Philips Healthcare
Reason: Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount - Philips Essenta DR, X-Ray System, Diagnostic, general-purpose Model: 712070
FDA Device · Class II · 2012-08-22 · Philips Healthcare
Reason: Essenta DR C-Arm may fall - Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Univer…
FDA Device · Class II · 2012-08-22 · Philips Healthcare
Reason: Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors. - Philips MultiDiagnost Eleva with Flat Detector (MD Eleva FD)Model: 708034 Product Usage: Philips X-ray System
FDA Device · Class II · 2012-08-15 · Philips Healthcare
Reason: When doing a 3 Dimensional Rotational Angiography (3DRA) the 3D reconstruction does not always start, even when all images have been acquired.