Z-2625-2023Class II

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

Name: Z-2625-2023 Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2023-08-24
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2023-08-24 / Open, Classified / root cause: design

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, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF... on 2023-08-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2625-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-24
Posted: 2023-09-21
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, and 00-1007, when Used With Tempus Pro Video Laryngoscope, REF 01-2044
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
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.
Root cause tag: design
FDA root cause: 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 [email protected]. 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2625-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2625-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-27	2023-09-21

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)