Z-1321-2023Class II

Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically...

Name: Z-1321-2023 Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2023-02-23
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2023-02-23 / Open, Classified

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or... on 2023-02-23. FDA classified it as Class II and gives the reason as "During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1321-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-23
Posted: 2023-04-01
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Product code: MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Reason for recall: During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.
FDA root cause: Under Investigation by firm
Action: On 02/17/2023, the firm sent an "URGENT Medical Device Correction" Letter via priority mail to customers informing them that during internal testing, Regulatory Compliance issues regarding Fluid Ingress and Basic Safety issues were identified with the Tempus Pro Monitor, AC Mains Power Supply, and the Vehicle Adaptor. Customers are instructed to: " As there is currently no indication that any of the issues have resulted in a degradation in product performance, Philips advises that the Tempus Pro devices should remain in service. " Continue to follow the User/Operator Manual, including: o Take care to ensure that water or liquids are not spilt over the device or into its ventilation holes in the side corners. o Check connector covers, particularly the capnometer door cover, to ensure they close and latch acceptably. " Post this Urgent Medical Device Correction letter on or near your Tempus Pro device. " Complete and return the Urgent Medical Device Correction response form included, no later than 30 days from receipt. Philips will be providing a new and compliant AC Mains Power Supply to all affected customers. A new and compliant Vehicle Adaptor will also be provided to affected customers with devices that include that option. Philips anticipates providing this solution to customers in the second half of 2023. For questions or further information, contact the local Philips Representative, or Philip at (800)263-3342.
Quantity in commerce: 5,540 units
Distribution: Worldwide Distribution: U.S.(nationwide): AL, AZ, 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 and O.U.S.(foreign): United Arab Emirates, Afghanistan, Austria, Australia, Belgium, Brunei Darussalam, Bolivia, Canada, Switzerland, Czechia, Germany, Denmark, Spain, France, United Kingdom, Hong Kong, Ireland, Israel, Iceland, Italy, Cayman Islands, Luxembourg, Malaysia, Netherlands, Norway, Portugal, Romania, Saudi Arabia, Sweden, Singapore, Slovenia, Thailand, Mayotte, and South Africa.
Product codes and lots: Model Numbers: 00-1004 00-1004-R UDI-DI Codes: 05060472440020 05060472442901 00-1007 00-1007-R UDI-DI Codes: 05060472440013 05060472442901 00-1024-R UDI-DI Codes: 05060472441027 05060472442925 00-1026-R UDI-DI Codes: 05060472441058 05060472442932 Lot Codes - All products manufactured are affected.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1321-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1321-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-04-12	2023-03-31

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)