Remote Diagnostic Technologies Ltd.: Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Recall number

Z-1729-2025

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

Status

Open, Classified

Initiated

2025-04-15

Posted

2025-05-07

Terminated

not on file

Reason

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

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 RDT.Recall.Response@Philips.com

Quantity

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.

Lot, serial or model codes

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

510(k) numbers

["K201746"]

PMA numbers

not on file

Product code

MHX

Firm FEI

3003832357

Firm city

Farnborough

Firm state

not on file

Firm country

United Kingdom

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy