CLASS II ONGOING Device recall · Reported 12 Apr 2023 · FDA Enforcement Report

Tempus Pro Patient Monitor is a portable vital signs recalled

Remote Diagnostic Technologies is recalling Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by, distributed nationwide in the US. The recall was initiated on 23 Feb 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled5,540 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1321-2023
FDA event ID: 91805
Recalling firm: Remote Diagnostic Technologies, Farnborough
Classification: Class II
Status: Ongoing
Recall initiated: 23 Feb 2023
FDA classified: 31 Mar 2023
Reported: 12 Apr 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Patient Monitors

Timeline

23 Feb 2023	Recall initiated by company
31 Mar 2023	Classified by FDA	+36 days
12 Apr 2023	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide Alabama Arizona California Colorado District of Columbia Delaware Florida Georgia Hawaii Iowa Idaho Illinois Indiana Kansas Kentucky Massachusetts Maryland Maine Michigan Minnesota

Questions about this recall

Is Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by recalled?

Yes. Remote Diagnostic Technologies recalled Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by on 23 Feb 2023. The recall is Class II and its status is Ongoing. Recall number Z-1321-2023.

Why was it recalled?

During internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety issues.

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Remote Diagnostic Technologies

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Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	Philips Tempus Pro Patient Monitor recalled	Remote Diagnostic Technologies	Lead & Heavy Metals	Nationwide
6 Aug 2025Device	CLASS II	Inseego USB8 Dongle Kit recalled by Remote Diagnostic Technologies	Remote Diagnostic Technologies	Lead & Heavy Metals	Nationwide
14 May 2025Device	CLASS II	Philips Tempus Pro Patient Monitor recalled	Remote Diagnostic Technologies	Labeling Errors	Nationwide
30 Apr 2025Device	CLASS II	Tempus Pro Patient Monitor, REFs: 00-1004-R recalled	Remote Diagnostic Technologies	Device Malfunction	Nationwide
4 Dec 2024Device	CLASS III	Tempus LS-Manual Defibrillator recalled	Remote Diagnostic Technologies	Labeling Errors	Nationwide

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