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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 Monitor see related information
Date Initiated by Firm August 24, 2023
Date Posted September 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2625-2023
Recall Event ID 92914
510(K)Number K201746  
Product Classification Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
Product Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
Code Information Monitors with hardware version: Trizeps-7, and software versions v07.26 through v07.30. 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
Recalling Firm/
Manufacturer		 Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough United Kingdom
For Additional Information Contact Philips Customer Services
800-7229377
Manufacturer Reason
for Recall		 Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required. Error prevents: viewing graphical patient vital signs, sounding of pulse audio tone, visualization of patient airway used during intubation; may lead to treatment delay or hypoxia.
FDA Determined
Cause 2		 Device Design
Action On 8/24/23 Correction Notices were mailed to customers and distributors who were asked to do the following: 1) If monitor has Trizeps-7 Hardware, remove the laryngoscope from service with this monitor. Users must use an alternative laryngoscope not connected to the Tempus Pro Monitor to manage the patient s airway to avoid interruption in patient care. The Tempus Pro Monitor can remain in service if the Tempus Pro Video Laryngoscope is not connected to the monitor. 2) If monitor has Trizeps-6 Hardware, the laryngoscope can continue to be used with the monitor. 3) Post this Urgent Medical Device Correction letter on or near the affected device. 4) Pass this notice on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred (if appropriate). 5) Complete and return the Urgent Medical Device Correction response form. Distributors were asked to take the following additional actions: If you have any Tempus Pro Video Laryngoscopes or any Tempus Pro Monitors in stock that have not been distributed, do not distribute them. Modify the response form to include your firm's contact information and then send the response form along with the customer correction notice to customers. If you need any further information or support contact the firm at (800) 722-9377 or email RDT.RecalI.Response@Philips.com. On 11/6/23, updated correction notices were distributed adding two additional models that could become affected if their hardware is updated. Additionally, the notices asked customers to install software (V07.34) on Tempus Pro Monitors according to installation instructions.
Quantity in Commerce 3,524
Distribution US:AZ, AL, CA, CO, DC, DE, FL , GA, HI, IA, ID, IL, IN , KS, KY, MA , MD , ME, MI, MN, MO, MS, MT, NC , ND, NE, NJ, NM , NV, NY, OH, OK, OR, PA, TN, TX, UT, VA , WA, WI, WV, WY. OUS: AE, AT, AU, BE, BN, BO, CA, CH, CZ, DE, DK, ES, FR, GB, HK, IE, IL, IS, IT, KY, LU, MY, NL, NO, OM, PT, RO, SA, SE, SG, SI, TH, YT, ZA
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = MHX and Original Applicant = Remote Diagnostic Technologies Limited
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