CLASS III ONGOING Device recall · Reported 4 Dec 2024 · FDA Enforcement Report

Tempus LS-Manual Defibrillator recalled

Remote Diagnostic Technologies is recalling Tempus LS-Manual Defibrillator, distributed nationwide in the US. The recall was initiated on 28 Oct 2024 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesModel Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582

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-0557-2025
FDA event ID: 95642
Recalling firm: Remote Diagnostic Technologies, Farnborough
Classification: Class III
Status: Ongoing
Recall initiated: 28 Oct 2024
FDA classified: 26 Nov 2024
Reported: 4 Dec 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Pacemakers & Defibrillators

Timeline

28 Oct 2024	Recall initiated by company
26 Nov 2024	Classified by FDA	+29 days
4 Dec 2024	Published in enforcement report	+8 days

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

Reason for recall

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Product as listed by the FDA

Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

Where it was distributed

U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.

Nationwide Alabama California Florida Missouri New York Ohio Texas Virginia

Questions about this recall

Why was it recalled?

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Which lots are affected?

Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582

Where was it sold?

U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 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

All 12

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	Philips Tempus Pro Patient Monitor recalled	Remote Diagnostic Technologies	Other	Nationwide
6 Aug 2025Device	CLASS II	Inseego USB8 Dongle Kit recalled by Remote Diagnostic Technologies	Remote Diagnostic Technologies	Device Malfunction	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 recalled	Remote Diagnostic Technologies	Device Malfunction	Nationwide
12 Jun 2024Device	CLASS II	Philips Tempus LS-Manual Defibrillator recalled	Remote Diagnostic Technologies	Other	Nationwide

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