PlainRecalls

Philips Electronics North America Corporation

Compiled from official public sources by the editorial team.

160 recalls on record · Latest: Dec 26, 2018

Philips Electronics North America Corporation Recall Insight

Philips Electronics North America Corporation appears on 160 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.157% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 26, 2018, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 0 critical, 48 moderate, and 2 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Sep 7, 2016 to Apr 25, 2018.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Apr 25, 2018

Intera 1.5T; 1) Intera 1.5T Omni/Stellar Model 781104, 2) Intera 1.5T Power/Pulsar Model 781105, 3) Intera 1.5T Master/Nova Model 781106, 4) Intera…

FDA Devices Moderate Apr 25, 2018

T5 Model 78104 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or spect…

FDA Devices Moderate Apr 25, 2018

ACS-NT, Model 78108 Product Usage: Indicated for use as a diagnostic device. It can produce cross-sectional images, spectroscopic images and/or s…

FDA Devices Moderate Apr 18, 2018

IntelliVue X3 Patient Monitor.

FDA Devices Low Mar 21, 2018

HeartStart XL+ Defibrillator/Monitor The HeartStart XL+ is intended for use in a hospital setting by qualified medical personnel trained in the op…

FDA Devices Moderate Mar 14, 2018

Philips Network Firewall (Cisco ASA 5506), Model # 867098

FDA Devices Moderate Mar 7, 2018

Allura Xper systems with Certeray X-ray Generator located in regions with high mains (480V) voltage. Product Usage: The Allura Xper series is int…

FDA Devices Moderate Mar 7, 2018

Intellivue iX Information Center Software - All PIIC iX Surveillance stations including: 866023 IntelliVue Info Center iX A.0 866117 PIIC Classic U…

FDA Devices Moderate Mar 7, 2018

Allura 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: Cardiov…

FDA Devices Moderate Mar 7, 2018

digital x-ray detector ProGrade R1 - solid state X ray imager (flat panel/digital imager) As a part of a radiographic system, the Philips ProGr…

FDA Devices Moderate Feb 28, 2018

Philips QCPR Meter - used with FR3 Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external de…

FDA Devices Moderate Feb 28, 2018

Philips QCPR Meter - used with MRx Product Usage: The Philips CPR meter is intended for use with the Philips HeartStart FR3 automated external de…

FDA Devices Moderate Jan 24, 2018

ECG 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 o…

FDA Devices Moderate Jan 17, 2018

CombiDiagnost R90 Image-Intensified fluoroscopic x-ray system CombiDiagnost R90 is a multi-functional general R/F system. It is suitable for all r…

FDA Devices Moderate Jan 10, 2018

Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray expo…

FDA Devices Moderate Jan 3, 2018

IntelliVue Multi Measurement Server, IntelliVue Multi Measurement Server SLCP, IntelliVue Multi Measurement Server X2, IntelliVue Patient Monitor Mod…

FDA Devices Low Dec 27, 2017

Philips SureSigns VSi / SureSigns VS2+ vital signs monitor used in healthcare environments and transport within a facility.

FDA Devices Moderate Dec 27, 2017

Azurion 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 p…

FDA Devices Moderate Dec 27, 2017

Automated External Defibrillator - HeartStart MRx Monitor/Defibrillator

FDA Devices Moderate Oct 25, 2017

Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional …

FDA Devices Moderate Oct 25, 2017

Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional im…

FDA Devices Moderate Oct 25, 2017

Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-secti…

FDA Devices Moderate Oct 25, 2017

Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectional ima…

FDA Devices Moderate Oct 25, 2017

Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-section…

FDA Devices Moderate Oct 25, 2017

Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These computed tomography x-ray systems are intended to produce cross-sectiona…

FDA Devices Moderate Jun 21, 2017

Philips DigitalDiagnost 3.1.x X-Ray System

FDA Devices Moderate Jun 21, 2017

M3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 8650…

FDA Devices Moderate Jun 21, 2017

Philips DuraDiagnost X-ray systems: DuraDiagnost (R1.0, Product Number 712210) DuraDiagnost (R2.0, Product Number 712211) DuraDiagnost (R3.0, Pro…

FDA Devices Moderate Jun 7, 2017

NMT Patient Cable (989803174581) in use with lntelliVue NMT Module (Part# 865383)

FDA Devices Moderate Apr 26, 2017

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;…

FDA Devices Moderate Apr 26, 2017

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). 7…

FDA Devices Moderate Apr 26, 2017

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 Ta…

FDA Devices Moderate Apr 12, 2017

Philips IntelliVue MX4O WLAN Patient Wearable Monitor Product: 865352 Exchange part (service numbers): 453564615311 TELE PWM,802.lla/b/g,ECG only,…

FDA Devices Moderate Mar 1, 2017

Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 central monitoring system is intended for use by healthcare professional…

FDA Devices Moderate Feb 1, 2017

Allura Xper FD20 R8.2 722028 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures…

FDA Devices Moderate Feb 1, 2017

Velara Generator with an old Firmware version used with the Philips Integris BH5000

FDA Devices Moderate Feb 1, 2017

Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center

FDA Devices Moderate Feb 1, 2017

Allura Xper FD10 722026 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (suc…

FDA Devices Moderate Feb 1, 2017

Allura Xper FD20/15 R8.2 722058 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedu…

FDA Devices Moderate Feb 1, 2017

Velara Generator with an old Firmware version used with Philips Allura Xper Systems (Allura 15 & 12 (monoplane), Allura FD10C, Allura FD10F, Allura F…

FDA Devices Moderate Feb 1, 2017

Allura Xper FD20 722012 is intended for: Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (suc…

FDA Devices Moderate Dec 28, 2016

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 …

FDA Devices Moderate Nov 30, 2016

Philips Healthcare System X-ray Tomography Computed :

FDA Devices Moderate Nov 30, 2016

Philips Healthcare System X-ray Tomography Computed :

FDA Devices Moderate Oct 26, 2016

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 Smart-hopping (2.4GHz) Product Number: 865351 Worldwide Except USA Exchange part: 453…

FDA Devices Moderate Oct 26, 2016

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 WMTS Smart-hopping (1.4GHz) Product Number: 865350 Exchange part: 453564262491 453564…

FDA Devices Moderate Oct 26, 2016

Philips IntelliVue MX40 Patient Monitor: IntelliVue MX40 802.11a/b/g Product Number: 865352 Exchange part: 453564262491 453564262511 453564615…

FDA Devices Moderate Sep 28, 2016

HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A

FDA Devices Moderate Sep 7, 2016

PCR Compano Basic Reader using 100-127V as mains voltage. Model numbers: 732027, 732028, and 732040. Radiological image processing system (Comp…

FDA Devices Moderate Sep 7, 2016

UNIQ 1.0: UNIQ FD10, 722026; UNIQ FD10/10, 722027; UNIQ FD20, 722028; UNIQ FD20/10 biplane, 722029; UNIQ FD10 OR Table, 722033; UNIQ FD10/10 OR Table…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Philips Electronics North America Corporation with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.