FDA recall, , Moderate risk
Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module
Philips Tempus Pro Patient Monitor measures ICP and BDR but these measurements are unvalidated, potentially leading to incorrect clinical decisions.
Summary by Recall Canary from the FDA notice
What happened
Remote Diagnostic Technologies Ltd. of Farnborough, United Kingdom, is recalling the Philips Tempus Pro Patient Monitor, REF 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, and the USB 2-Channel IBP Module, REF 01-2017. The monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR), but these measurements have not been tested or validated for accuracy.
If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions. The recall began November 26, 2025, and the FDA added it to its Enforcement Report on January 8, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
- UDI-DI
- 05060472440624
- 05060472440655
- 05060472440020
- 05060472442901
- 05060472440013
- 05060472442918
- 05060472441027
- 05060472442925
- 05060472441058
- 05060472442932
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of Arizona, Virginia, Florida, California, Texas, New Mexico, Iowa, New Jersey, Tennessee, Ohio, Kansas, Indiana, North Carolina, Illinois, Wyoming, Wisconsin, Nevada, New York, Nebraska, Pennsylvania, Alabama, Massachusetts, Georgia, Missouri, Colorado, Oklahoma, Kentucky, Oregon, Mississippi, Michigan, Hawaii, Washington, Utah, West Virginia, Idaho, North Dakota, New Hampshire, Minnesota, Montana, Maine, Maryland, Delaware and the countries of AU, GB, IT, SA, Delaware, AE, BO, FR, ES, BE, Illinois, SG, California, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, Kentucky, OM, CZ, SI, SL, GI, ZA, AF, SE, FI.
- Company
- Remote Diagnostic Technologies Ltd.Farnborough, United Kingdom
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 97889
- Recall number
- Z-1027-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
