PHILIPS Xper Flex Cardio Physiomonitoring System
US1433000052
Lower-risk recall
The real-time numeric value for ventricular end-diastolic pressure (EDP) displayed on the Live Display may be inaccurate. Because ventricular pressure monitoring is only performed in the cardiac catheterization procedure room using the FC2010 device, the FC2020 device, which is used in the Pre or Post-Op Holding Areas, is not impacted by this issue.
Contact the company
What happened, in plain English
US1433000052 Read more at govinfonow.com/recall/71713-us1433000052.
Source Summary by GovInfoNow · govinfonow.com/recall/71713-us1433000052 · Updated August 27, 2026 · FDA enforcement record: FDA #Z-1867-2018
Cite this page
“PHILIPS Xper Flex Cardio Physiomonitoring System.” GovInfoNow, updated August 27, 2026. https://govinfonow.com/recall/71713-us1433000052. Based on FDA recall #Z-1867-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1867-2018%22&limit=1).
Why it’s dangerous
This product is a US patent number. Patent numbers are not dangerous by themselves, but they can be used to identify specific products or technologies that may be subject to legal restrictions or intellectual property concerns. In this context, the product is likely a medical device or related product, and the patent number indicates it is protected by US patent law. The presence of multiple patent numbers suggests that the product may be part of a family of related patents or products.
Who’s affected
all
How to tell if you have this one
US patent numbers, particularly those that are part of a medical device or related product. The presence of multiple patent numbers may indicate a complex product with multiple components or variations.
- Brand
US1433000052- Product
PHILIPS Xper Flex Cardio Physiomonitoring System, Model Numbers: 453564241901, 453564483321, 453564621791, and- Category
Medical device
What to do — step by step
1
Verify the product's intended use and regulatory status. Patent numbers alone do not indicate danger, but they can be used to identify specific products that may require regulatory approval or certification.
2
Check the product's documentation for any warnings or restrictions related to its use, especially if it is a medical device.
3
Consult with a legal expert specializing in intellectual property law to ensure compliance with patent regulations and to understand any potential restrictions.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico., and to the countries of : Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Cyprus, Egypt, Finland, France, Germany, Greece,…” 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 terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What is a US patent number?
A US patent number is a unique identifier assigned by the United States Patent and Trademark Office (USPTO) to a specific patent application or granted patent. It helps track the patent's status and provides information about the invention it covers.
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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-1867-2018 (March 14, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1867-2018 to see it in context.
- Plain-language summary written by qwen3:4b on August 27, 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.