PlainRecalls

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

117 recalls on record · Latest: Feb 18, 2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Recall Insight

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. appears on 117 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.139% 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 Feb 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 50 entries, severity tagging shows 11 critical, 39 moderate, and 0 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 Feb 28, 2024 to May 21, 2025.

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 May 21, 2025

SmartPath to dStream for 3.0T, Model Number: 782145;

FDA Devices Moderate May 21, 2025

Intera 1.5T Explorer/Nova Dual, Model Number: 781108;

FDA Devices Moderate May 21, 2025

SmartPath to dStream for 1.5T, Model Number: 782146;

FDA Devices Moderate May 21, 2025

Intera 1.0T Omni/Stellar, Model Number: 781102;

FDA Devices Moderate May 21, 2025

Enterprise 1.5T, Model Number: 781145;

FDA Devices Moderate May 21, 2025

Intera 1.5T Omni/Stellar, Model Number: 781104;

FDA Devices Moderate May 21, 2025

Intera 0.5T Standard, Model Number: 781101;

FDA Devices Moderate May 21, 2025

Intera 3.0T Quasar Dual, Model Number: 781150;

FDA Devices Moderate May 21, 2025

Intera 1.5T Power/Pulsar, Model Number: 781105;

FDA Devices Moderate May 21, 2025

Intera 1.5T R11, Model Number: 781170;

FDA Devices Moderate May 14, 2025

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

FDA Devices Moderate Apr 30, 2025

Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environmen…

FDA Devices Moderate Mar 19, 2025

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;

FDA Devices Critical Feb 26, 2025

Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013.

FDA Devices Critical Feb 26, 2025

Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

FDA Devices Critical Feb 26, 2025

Allura CV20; Catalog numbers: 722031

FDA Devices Critical Feb 26, 2025

Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 722282 (OUS ONLY);

FDA Devices Critical Feb 26, 2025

Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221.

FDA Devices Critical Feb 26, 2025

Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028.

FDA Devices Critical Feb 26, 2025

Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025.

FDA Devices Critical Feb 26, 2025

Allura Xper FD20/15; Catalog numbers: 722058

FDA Devices Critical Feb 26, 2025

Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY).

FDA Devices Critical Feb 26, 2025

Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035.

FDA Devices Critical Feb 26, 2025

Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236.

FDA Devices Moderate Feb 12, 2025

Azurion 3 M12 System Code: (1) 722063 (2) 722221

FDA Devices Moderate Feb 12, 2025

Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235

FDA Devices Moderate Feb 12, 2025

Allura CV20 System Code: 722031

FDA Devices Moderate Feb 12, 2025

Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236

FDA Devices Moderate Feb 12, 2025

AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028

FDA Devices Moderate Feb 12, 2025

AlluraXperFD20/10 System Code: (1) 722029

FDA Devices Moderate Feb 12, 2025

AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013

FDA Devices Moderate Feb 12, 2025

Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233

FDA Devices Moderate Feb 12, 2025

AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035

FDA Devices Moderate Feb 12, 2025

AlluraXperFD20/15 System Code: (1) 722058

FDA Devices Moderate Feb 12, 2025

Azurion 5 M12 System Code: (1) 722227 (2) 722231

FDA Devices Moderate Feb 12, 2025

AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027

FDA Devices Moderate Feb 12, 2025

Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026

FDA Devices Moderate Feb 12, 2025

Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281

FDA Devices Moderate Dec 18, 2024

Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Nu…

FDA Devices Moderate Sep 25, 2024

System Code Name: 722282 Azurion 7 M20 722281 Azurion 5 M20 722236 Azurion 7 B20 722235 Azurion 7 B12 722234 Azurion 7 M20 722233 Azurion 7 M12 72222…

FDA Devices Moderate Sep 25, 2024

System Name: 722044 INTEGRIS Allura 15-12 (biplane) 722030 Integris CV Cesar-Powerpack-Visub-Nicol 722021 INTEGRIS Allura 9 (biplane) 722018 Integris…

FDA Devices Moderate Sep 25, 2024

System Name: 722059 Allura Xper FD20/15 OR Table 722058 Allura Xper FD20/15 722039 Allura Xper FD20/20 OR Table 722038 Allura Xper FD20/20 722035 All…

FDA Devices Moderate Sep 25, 2024

System Name: 708038 MultiDiagnost Eleva with Flat Detector 708037 MultiDiagnost Eleva with Flat Detector 708036 MultiDiagnost Eleva 708034 MultiDiagn…

FDA Devices Moderate Sep 11, 2024

Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluoroscopic X-Ray System, Model Numbers 722079 and 722224

FDA Devices Moderate Aug 28, 2024

Philips Allura Xper systems (R8.1 with Poly-G Stand) Interventional Fluoroscopic X-Ray System, Model Numbers 722010, 722012, 722013

FDA Devices Moderate Aug 14, 2024

Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, …

FDA Devices Moderate Jun 5, 2024

Philips Allura Xper FD10 system with an ADN7NT patient table. Model Number: 722010, Software Version Number 8.1.100.

FDA Devices Moderate Jun 5, 2024

Philips Allura Xper FD20 Biplane system with an ADN7NT patient table. Model Number: 722013, Software Version Number 8.1.100.

FDA Devices Moderate Jun 5, 2024

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

FDA Devices Moderate Feb 28, 2024

Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: Fle…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

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