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Use caution Medical device recall · FDA · Published April 15, 2025

Philips Tempus Pro Patient Monitor Software Update Recalls: Freezing and Inaccurate ECG

Philips recalls Tempus Pro Patient Monitors with software versions prior to vx.40 due to freezing issues and inaccurate 12-lead ECG readings. Affected models include 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007.

🇺🇸 FDA recall #Z-1729-2025Medical devicePhilips ›
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Recalling firmRemote Diagnostic Technologies Ltd.Farnborough Aerospace Centre, Aerospace Boulevard · Farnborough, United Kingdom
✎ GovInfoNow plain-language explainer

Philips is recalling Tempus Pro Patient Monitors with software versions before vx.40 because they can freeze during startup, ECG tests, or smart mount connections, and may give inaccurate heart rhythm readings. This could lead to incorrect medical decisions if the monitor is used for patient monitoring. Read more at govinfonow.com/recall/52451-philips-tempus-pro-patient-monitor-software-update-recalls-freezing-and.

Source Summary by GovInfoNow · govinfonow.com/recall/52451-philips-tempus-pro-patient-monitor-software-update-recalls-freezing-and · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1729-2025

Cite this page

“Philips Tempus Pro Patient Monitor Software Update Recalls: Freezing and Inaccurate ECG.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52451-philips-tempus-pro-patient-monitor-software-update-recalls-freezing-and. Based on FDA recall #Z-1729-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1729-2025%22&limit=1).

The FDA announced on April 15, 2025, that Remote Diagnostic Technologies Ltd. is recalling Philips Tempus Pro Patient Monitors due to software issues that may cause the device to freeze or produce inaccurate ECG data. Owners should contact the company for a software update.

How to tell if you have it

  • Brand: Philips
  • Product: Tempus Pro Patient Monitor
  • REFs: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
  • Software versions prior to vx.40
  • Units affected: 6961

The hazard

The monitor's software may freeze at startup or during ECG measurements, potentially causing inaccurate rhythm statements. The FDA cited these issues as the basis for the Class II recall.

Context

GovInfoNow's records show Remote Diagnostic Technologies Ltd. has 11 other recalls on record since November 17, 2020. Other recent recalls of similar products include a Tempus Pro Patient Monitor software error dated April 16, 2025, and an Inseego USB8 4G Dongle Kit recall dated May 30, 2025. Philips Cardiac Workstation 5000 and 7000 recalls regarding inaccurate heart rate data were reported on July 1, 2026.

How to tell if you have this one

Check the product's software version (prior to vx.40) or the model reference numbers listed: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007.

  • Brand
    Philips
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Review the monitor's software version to confirm it is prior to vx.40.

  2. Update Software

    Update to software version vx.40 or later to fix the freezing and accuracy issues.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 42 states.

Alaska: nationwideAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of AZ, VA, FL, CA, TX, NM, IA, NJ, TN, OH, KS, IN, NC, IL, WY, WI, NV, NY, NE, PA, AL, , MA, GA, MO, CO, OK, KY, OR, MS, MI, HI, WA, UT, WV, ID, ND, NH, MN, MT, ME, MD, DE, DC…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 29 days after the firm started it.

1. Firm started the recall: Apr 15, 202512. FDA classified it Class II: May 7, 202523. Published in FDA’s Enforcement Report: May 14, 202532025
  1. Firm started the recall
  2. FDA classified it Class II
  3. 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-1729-2025 (April 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1729-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA