PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Philips Medical Systems
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is a leading manufacturer of medical imaging systems and solutions. They provide advanced imaging equipment for hospitals and healthcare facilities worldwide.
Lower-risk recall
Potential for temporary loss of imaging (X-ray) functionality due to software issue.
Contact the company
What happened, in plain English
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. is a leading manufacturer of medical imaging systems and solutions. They provide advanced imaging equipment for hospitals and healthcare facilities worldwide. Read more at govinfonow.com/recall/51943-philips-medical-systems-nederland-b-v-philips-medical-systems.
Source Summary by GovInfoNow · govinfonow.com/recall/51943-philips-medical-systems-nederland-b-v-philips-medical-systems · Updated August 10, 2026 · FDA enforcement record: FDA #Z-2189-2025
Cite this page
“PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. - Philips Medical Systems.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/51943-philips-medical-systems-nederland-b-v-philips-medical-systems. Based on FDA recall #Z-2189-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2189-2025%22&limit=1).
Why it’s dangerous
The data shows a list of medical imaging system identifiers and their associated codes. This could be used to identify specific medical equipment in hospitals or healthcare facilities. However, the data does not contain sensitive personal health information, so the risk level is considered low.
Who’s affected
All users of medical imaging systems from Philips Medical Systems Netherlands B.V.
How to tell if you have this one
Look for medical imaging system identifiers and their associated codes in the data. These identifiers are typically used to track and manage medical equipment in healthcare facilities.
- Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.- Product
Philips Allura R8.2.x Systems. Software Verion: R8.2.x. 1. Allura Xper FD10, Model Number: 722026. 2. Allura Xper- Category
Medical device
What to do — step by step
What to do with the data
The data provided is a list of medical imaging system identifiers and their associated codes. This information is typically used for internal tracking and management of medical equipment in healthcare facilities. There is no indication of sensitive personal health information being exposed.
Risk assessment
The risk level is considered low because the data does not contain sensitive personal health information. The identifiers are used for internal purposes within healthcare facilities and are not typically shared externally.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide - US Nationwide and the countries of Algeria, Argentina, Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Brazil, Bulgaria, Canada, Cayman Islands, Chile, China, Colombia, Costa Rica, Croatia, Cuba, Cyprus, Czech…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2189-2025 (June 30, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2189-2025 to see it in context.
- Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.