PlainRecalls

Philips Medical Systems Nederland B.v.

Compiled from official public sources by the publisher.

209 recalls on record · Latest: Aug 19, 2026

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Agency notice ledger

Federal filing book Philips Medical Systems Ned… HEAVY-BOOK · SINGLE-AGENCY

#66 of 14,151 · 209 notices · 0.200% archive

  • BOOK 209 notices
  • RANK #66 of 14,151
  • SHARE 0.200% archive
  • AGENCY FDA Devices (209)
  • CAT medical devices
  • CATS 1 category
  • LATEST Aug 19, 2026
  • PHOTO Exactech, Inc.

Nearest notice-volume peer: Exactech, Inc. (2 notice gap)

Philips Medical Systems Nederland B.v. accounts for about 0.200% of the 104,423-notice archive on 209 distinct filings — a heavy share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Philips Medical Systems Ned… compares to 14,151 recalling firms

Philips Medical Systems Nederland B.v. ranks 66th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Philips Medical Systems Ned… vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

209 66th of 14151 higher than 14,085 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13

Philips Medical Systems Ned… in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Philips Medical Systems Nederland B.v. holds about 0.200% of archive notices alongside 209 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Oct 1, 2025

Allura Xper FD20 Biplane OR Table Product Codes: (1)722020, (2) 722025; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Devices Moderate Oct 1, 2025

Allura Xper FD20 Product Codes: (1)722012, (2) 722028, (3) 722006; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Devices Moderate Oct 1, 2025

Allura Xper FD20/20; Product Code: 722038; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Devices Moderate Oct 1, 2025

Allura Xper FD20/10; Product Code: 722029; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Devices Moderate Sep 17, 2025

IntelliSpace Cardiovascular, Software 8.0.0.4.
FDA Devices Moderate Sep 10, 2025

Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion
FDA Devices Moderate Sep 10, 2025

Philips Allura System configured with a 1 Phase UPS. Allura family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003 2. Allura Xper FD10/10, Model Number 722005 3. Allura Xper FD20, Model Number 722006 4. Allura Xper FD20 Biplane, Model Number 722008 5. Allura Xper FD10, Model Number 722010 6. Allura Xper FD10/10, Model Number 722011 7. Allura Xper FD20, Model Number 722012 8. Allura Xper FD20 Biplane, M
FDA Devices Moderate Sep 10, 2025

Interventional Fluoroscopic X-Ray System - Philips Allura Xper Series. Labeled as the following with corresponding model numbers: 1. Allura Xper FD10, Model Number 722003. 2. Allura Xper FD10/10, Model Number 722005. 3. Allura Xper FD20, Model Number 722006. 4. Allura Xper FD20 Biplane, Model Number 722008. 5. Allura Xper FD10, Model Number 722010. 6. Allura Xper FD10/10, Model Number 722011. 7. Allura Xper FD20, Model Number 722012. 8. Allura Xper FD20 Biplane, Mo
FDA Devices Moderate Aug 6, 2025

Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper FD10/10, Model Number: 722027. 3. Allura Xper FD20, Model Number: 722028. 4. Allura Xper FD20/10, Model Number: 722029. 5. Allura Xper FD10 OR Table, Model Number: 722033. 6. Allura Xper FD20 OR Table, Model Number: 722035. 7. Allura Xper FD20/20, Model Number: 722038 8. Allura Xper FD20/20 OR Table, Model Number: 722039. 9. Allura Xper FD20/15, Model N
FDA Devices Moderate Jul 30, 2025

Azurion 7 M20. Fluoroscopic X-Ray System.
FDA Devices Moderate Jun 18, 2025

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;
FDA Devices Moderate May 21, 2025

Intera 1.5T Master/Nova, Model Number: 781106;
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 21, 2025

Intera 1.5T, Model Numbers: 781195 and 781295;
FDA Devices Moderate May 21, 2025

Intera 1.0T Power/Pulsar, Model Number: 781103;
FDA Devices Moderate May 21, 2025

Intera CV, Model Number: 781107;
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 environment in a variety of procedures.
FDA Devices Moderate Mar 19, 2025

Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
FDA Devices Moderate Mar 12, 2025

Philips IntelliSpace Cardiovascular software, Model 830089.
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 Critical Feb 26, 2025

Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).
FDA Devices Critical Feb 26, 2025

Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY).
FDA Devices Critical Feb 26, 2025

Allura Xper FD20/10; Catalog numbers: 722029
FDA Devices Critical Feb 26, 2025

Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026,
FDA Devices Critical Feb 26, 2025

Allura Xper FD10C; Catalog number: 722001
FDA Devices Critical Feb 26, 2025

Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY).
FDA Devices Critical Feb 26, 2025

Allura Xper FD20/20; Catalog numbers: 722038
FDA Devices Critical Feb 26, 2025

Azurion 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281 (OUS ONLY).
FDA Devices Critical Feb 26, 2025

Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027.
FDA Devices Moderate Feb 12, 2025

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

Philips Medical Systems Ned… carries an outsized archive share

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (209 here — heavy-book).

Exactech, Inc. 211 Medtronic Vascular 211 Volkswagen 207 Teleflex Medical 204 Terumo Cardiovascular Systems Corporation 204

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Exactech, Inc. 211 Medtronic Vascular 211 Teleflex Medical 204 Terumo Cardiovascular Systems Corporation 204

Frequently Asked Questions

How many federal recall notices name Philips Medical Systems Ned…? ▼
PlainRecalls indexes 209 distinct federal recall events naming Philips Medical Systems Nederland B.v., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Philips Medical Systems Ned… sit among other recalling firms? ▼
Philips Medical Systems Nederland B.v. ranks #66 of 14,151 by distinct recall-event count among 14,151 firms in this archive (99th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Philips Medical Systems Ned…'s notices? ▼
FDA Devices accounts for 209 of this firm's 209 indexed notices.
What product category dominates Philips Medical Systems Ned…'s filing book? ▼
Filings for Philips Medical Systems Nederland B.v. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Philips Medical Systems Nederland B.v.: 209 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Philips Medical Systems Nederland B.v.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026