Z-1729-2025Class II

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Name: Z-1729-2025 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Creator: Remote Diagnostic Technologies Ltd.
Published: 2025-04-15
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2025-04-15 / Open, Classified / root cause: software

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 on 2025-04-15. FDA classified it as Class II and gives the reason as "Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1729-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-15
Posted: 2025-05-07
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.
Root cause tag: software
FDA root cause: Software design
Action: On 4/15/2025, correction notices were mailed to customers and distributors informing them of the following: I) The User/Operator Manual provides precautions and warnings on maintaining appropriate power or battery supply, which may reduce the risk of occurrence of an "MPM Application" software error message: -Warning (In Chapter 2, Getting started): Ensure the latches on both sides of the battery are fully engaged prior to using the Tempus - an incorrectly fitted battery could result in the tempus losing power during use. -Note: Before removing the battery, you must switch off the Tempus Pro by pressing the power button. Do not remove the battery when the Tempus is on (unless there is a power supply attached to the device). II) If you have confirmed that your Tempus Pro has the standard (Louvain) algorithm, continue to follow the User/Operator Manual, which warns users to not make evaluations based solely on interpretation statements from the algorithm. -Warning (In Chapter 6, Taking medical readings): ECG interpretation performed by software is not a substitute for review and evaluation of ECG recordings by a qualified clinician. Keep a copy of this notice with your device until you receive the correction. Complete and return the response form via email to https://philips.efmfeedback.com/se/705E3ED80DE11FAF In addition, distributors were asked to do the following: - Modify the Response Form to substitute your firm's email and fax information. - Send a copy of this Urgent Medical Device Correction (with modified response form) to each customer to whom you distributed the affected product. Philips has developed a software update to resolve these issues that is expected to be available Q3 2025 via FCO86700012. If you need any further information or support concerning this issue, please contact the firm at (800) 722-9377 or email [email protected]
Quantity in commerce: 6961
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 and the countries of AU, GB, IT, SA, DE, AE, BO, FR, ES, BE, IL, SG, CA, IE, TH, NL, MY, AT, DK, RO, CH, IS, PT, NO, HK, PL, KY, OM, CZ, SI, SL, ZA, AF, SE, FI.
Product codes and lots: Software versions prior to vx.40. REF/UDI-DI: 00-1004-R/05060472440020, 05060472442901; 00-1007-R/05060472440013, 05060472442918; 00-1024-R/05060472441027, 05060472442925; 00-1026-R/05060472441058, 05060472442932; 00-1004/05060472440624; 00-1007/05060472440655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1729-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1729-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-07

Product code MHX

K201746Class IITempus Pro Patient MonitorRemote Diagnostic Technologies Limited / cleared 2020-09-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)