Recall Register

Philips Electronics North America Corporation: FDA recalls

FDA enforcement reports name Philips Electronics North America Corporation as the recalling firm in 61 events. The events have 160 product records. The recalls started from 2010 to 2018. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

61 events, newest first.

FDA enforcement events of Philips Electronics North America Corporation
InitiatedProduct (first record)TypeClassRecordsStatus
15 Nov 2018Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081DeviceClass II1Terminated
10 Oct 2018IntelliVue MX40 Patient Monitor, Model Nos. 865350, 865351, 865352, 867146 - Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological…DeviceClass II1Ongoing
16 Jul 2018INTEGRIS Allura 9, System Code 722018 Vascular, cardiovascular and neurovascular imaging applications, Cardiac imaging applications including diagnostics, Non-vascular interventionsDeviceClass II27Terminated
13 Jul 2018Philips SureSigns VSV (Vital Signs Viewer), 863067 Indicated for central monitoring of multiple adult, pediatric and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric and neonatal patients to gain information for the treatment, to monitor adequacy of treatment, or to…DeviceClass II5Ongoing
3 May 2018HeartStart MRx Monitor/Defibrillator, Model No. M3535A (861288), M3536A (861289) Product Automated external defibrillators (non-wearable) Product Usage: The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel…DeviceClass II1Terminated
30 Apr 2018IntelliVue MX40 Patient Monitor, Software Versions B.05, B.06, B.06.5X, Model 865350DeviceClass II4Terminated
16 Mar 2018Multiva systems, 1) Multiva 1.5T 8 R5 Model 781072, 2) Multiva 1.5T 16 R5 Model 781073, 3) Multiva 1.5T 8ch R5 based Model 781074, 4) Multiva 1.5T Model 781076, & 5) Multiva 1.5T 16ch R5 based Model 781078 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic…DeviceClass II13Terminated
14 Mar 2018Allura Xper R8.x.25.5 and UNIZ systems (only with a FlexVision large screen monitor), Interventional fluoroscopic x-ray system Product Usage: The Allura Xper ED series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic,…DeviceClass II1Terminated
7 Feb 2018HeartStart XL+ Defibrillator/Monitor 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 defibrillation. It must be used by or on the order of a physician. When…DeviceClass III1Terminated
29 Jan 2018Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external defibrillators (FR3) with PR2.0 or higher software or on HeartStart MRx devices with software version F.01/R.01 or F.02/R.02 installed. The Q-CPR option provides feedback…DeviceClass II2Terminated
4 Jan 2018Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive…DeviceClass II1Terminated
3 Jan 2018Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic Upgrade 866389 IntelliVue Info Center iX B.0, C.0 867141 IntelliVue Info Center iX B.0 866025 IntelliVue Server IX A.0 866118 Database Server Upgrade A.0DeviceClass II1Terminated
20 Dec 2017Allura Xper FD and and Xper FD ORT - Philips X-ray Systems Product Usage: The Allura Xper FD10 and Alllura Xper FD10/10 is intendd for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and…DeviceClass II1Terminated
11 Dec 2017digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGrade is intended to acquire, process, store, display, and export digital radiographic images. The Philips ProGrade is suitable for all routine radiographic examinations,…DeviceClass II1Terminated
17 Nov 2017IntelliVue X3 Patient Monitor.DeviceClass II1Terminated
19 Oct 2017CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all routine radiography and fluoroscopy exams, including specialist areas like angiography or pediatric work, excluding mammographyDeviceClass II1Terminated
5 Oct 2017Philips Network Firewall (Cisco ASA 5506), Model # 867098DeviceClass II1Terminated
28 Sep 2017Automated External Defibrillator - HeartStart MRx Monitor/DefibrillatorDeviceClass II1Terminated
20 Sep 2017Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.DeviceClass III1Terminated
23 Aug 2017IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Models MP2 and MP5 Product Usage: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended…DeviceClass II1Ongoing
18 Aug 2017Azurion 3 M12, Azurion 3 M15, Allura R9 7 M12, Allura R9 M20, Azurion 7 M12, Azurion 7 M20 The Allura Xper series is intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes,…DeviceClass II1Terminated
17 Jul 2017ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables All units of Philips sync cables model M1783A and M5526A as well as Philips ECG out cables model 989803195641. Manufactured - September 4, 2002 October 8, 2014DeviceClass II1Terminated
14 Jul 2017Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.DeviceClass II1Terminated
31 May 2017Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Product Number 712211)DeviceClass II1Terminated
11 May 2017Philips DigitalDiagnost 3.1.x X-Ray SystemDeviceClass II1Terminated
4 May 2017NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)DeviceClass II1Terminated
22 Mar 2017Allura 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 722038; Allura Xper FD20/20 biplane OR…DeviceClass II3Terminated
6 Mar 2017Philips 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 whenever there is a need for monitoring the…DeviceClass II1Terminated
18 Jan 2017Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.DeviceClass II6Terminated
17 Jan 2017Philips 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 signs monitors) for multiple patients.…DeviceClass II1Terminated
27 Dec 2016Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information CenterDeviceClass II1Terminated
9 Dec 2016Velara 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)DeviceClass II2Terminated
1 Dec 2016Allura 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).DeviceClass II4Terminated
1 Dec 2016Ingenia 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 neurosurgical procedures in the near…DeviceClass II1Terminated
19 Sep 2016Philips 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 for use by health care professionals whenever there is…DeviceClass II3Terminated
26 Aug 2016HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536ADeviceClass II1Terminated
12 Aug 2016PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Computed Radiography).DeviceClass II1Terminated
26 Jul 2016IntelliVue 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 alarms for, multiple physiological…DeviceClass II1Terminated
19 Jul 2016MultiDiagnost Eleva with Flat Detector; x-ray system. Product Codes: 708034, 708037, 708038.DeviceClass II3Terminated
7 Jul 2016Allura 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 FD20/20 , 722038; Allura Xper FD20/20 biplane OR…DeviceClass II2Terminated
14 Apr 2016HeartStart 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 support, advanced cardiac support, or…DeviceClass II1Terminated
15 Mar 2016Philips Healthcare System X-ray Tomography Computed :DeviceClass II2Terminated
10 Feb 2016evaluemed 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 occurDeviceClass II2Terminated
4 Jan 2016Philips IntelliVue Measurement Module X1 Model: M3001ADeviceClass II2Terminated
25 Nov 2015Philips Healthcare IntelliVue Info Center iX, A.0 866023DeviceClass II3Terminated
20 Nov 2015Cardinal Health Tiny Toes; 11470-010T Infant heel warmerDeviceClass II1Terminated
3 Nov 2015Philips Allura Xper FD20 Ceiling version only; 722028; imaging applications.DeviceClass II2Terminated
3 Nov 2015Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 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).DeviceClass II29Terminated
14 Oct 2015Philips HeartStart MRx Monitor/Defibrillator; M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6. For use for the termination of ventricular tachycardia and ventricular fibrillation.DeviceClass II1Terminated
1 Oct 2015Philips 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 atherectomies), pacemaker implantations and…DeviceClass II1Terminated
17 Sep 2015Philips DuraDiagnost stationary X-ray systemDeviceClass II1Terminated
22 Jul 2015Philips Healthcare TraumaDiagnost; Codes: 72001, 720011, 720013, 720020; A radiological examination unit for emergency work and routine skeletal diagnosis.DeviceClass II1Terminated
6 Jul 2015SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR systemDeviceClass II1Terminated
6 Jul 2015Actuator 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; 722008 Allura Xper FD20 Biplane; 722010…DeviceClass II1Terminated
17 Jun 2015Invivo Expression MRI Patient Monitoring System.DeviceClass II1Terminated
5 Jun 2015Philips HeartStart XL+ Defibrillator/Monitor Product Usage: 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 defibrillation. When operating as a semi-automatic…DeviceClass II1Terminated
14 Apr 2015Philips Healthcare Brilliance 64 Computed Tomography X-ray systemDeviceClass II4Terminated
23 Mar 2015Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians.DeviceClass II1Terminated
19 Nov 2014ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+DeviceClass II1Terminated
31 Jul 2014Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. UPDATED: Pinnacle3 Software Version 8.0h, 8.0k, 8.0m, 8.0n.DeviceClass II1Terminated
17 Dec 2010M3150 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 display physiologic waves, parameters and…DeviceClass II1Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Philips Electronics North America Corporation: events for each product type
TypeEvents
Device61
Philips Electronics North America Corporation: events in each class
ClassEvents
Class II59
Class III2
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
3

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Philips Electronics North America Corporation, by the year that the recall started. The largest year is 2017, with 18 events.

Official channels

Cite this page

Recall Register. Philips Electronics North America Corporation: FDA recalls. https://recallregister.com/firm/philips-electronics-north-america-corporation/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Philips Electronics North America Corporation have?
Class II: 59 events. Class III: 2 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Philips Electronics North America Corporation?
FDA event 81527, which the firm started on 15 Nov 2018. The first product in the record is: Xper Flex Cardio Physiomonitoring System, Software versions 1.5.16.0322 and 1.6.1.0390, Model Numbers 453564241901, 453564241911, 453564483321, 453564483331, 453564621791, 453564621801, 453564669081
How many FDA recalls of Philips Electronics North America Corporation have the status Ongoing?
3 events have the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.