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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 16, 2025
Date PostedApril 24, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1666-2025
Recall Event ID 96678
510(K)NumberK130773 K201746 
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
ProductTempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Code Information All Lots/ UDI-DI(s): 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
1800-7229377
Manufacturer Reason
for Recall		software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
FDA Determined
Cause 2		Device Design
ActionOn April 16, 2025, Remote Diagnostic Technologies Ltd (subsidiary of Philips) issued a Urgent Medical Device Correction to affected consignees via mail. Philips ask consignees to take the following: 1. DO NOT connect the Video Laryngoscope USB probe to the Tempus Pro during device boot-up. Once Patient Details dialog appears, enter patient data, then plug in the Video Laryngoscope USB probe. 2. If the Tempus Pro Monitor displays the error dialog screen (where the user is asked to restart the device), press the Shutdown Button and restart the Tempus Pro Monitor. 3. Keep a copy of this letter with or near your Tempus Pro Monitor. 4. Complete and return the Urgent Field Safety Notification Response Form included with this letter within 30 days of receipt of this notice. 5. This notice must be shared with all relevant personnel within your organization and with any organization where the potentially affected devices have been transferred.
Quantity in Commerce6,961 units
DistributionWorldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, WI, WV, WY and the countries of AE, AF, AT, AU, BE, BO, CA, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IS, IT, KY, MY, NL, NO, OM, PL, PT, RO, SA, SE, SG, SI, SL, TH, ZA.
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
510(K)s with Product Code = MHX
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