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U.S. Department of Health and Human Services

Class 2 Device Recall Tempus Pro Patient Monitor

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 Class 2 Device Recall Tempus Pro Patient Monitorsee related information
Date Initiated by FirmApril 15, 2025
Date PostedMay 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1729-2025
Recall Event ID 96719
510(K)NumberK201746 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductPhilips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007
Code Information 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
FEI Number 3003832357
Recalling Firm/
Manufacturer		 Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough United Kingdom
For Additional Information ContactPhilips Customer Services
800-722-9377
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn 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 in Commerce6961
DistributionWorldwide - 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MHX
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