UnratedMedical device recall · FDA · Published January 28, 2022
Tempus LS Defibrillator Not Approved for US Market - Recall
Remote Diagnostic Technologies recalls Tempus LS defibrillators with specific software and serial numbers due to not being approved for US distribution. Affected units may pose safety risks.
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
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Contact the company
📍Recalling firmRemote Diagnostic Technologies Ltd.PAVILION C2, ASHWOOD PARK, ASHWOOD WAY · Basingstoke, United Kingdom
✎ GovInfoNow plain-language explainer
Remote Diagnostic Technologies is recalling Tempus LS defibrillators with specific software versions and serial numbers because they were not approved for sale in the US market. This recall is important because unapproved medical devices could pose safety risks to users. Read more at govinfonow.com/recall/61210-tempus-ls-defibrillator-not-approved-for-us-market-recall.
“Tempus LS Defibrillator Not Approved for US Market - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61210-tempus-ls-defibrillator-not-approved-for-us-market-recall. Based on FDA recall #Z-0861-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0861-2022%22&limit=1).
The FDA announced on Jan. 28, 2022, that Remote Diagnostic Technologies Ltd. is recalling two Tempus LS defibrillators distributed in Illinois and Kansas because they were not approved or cleared for the U.S. market.
How to tell if you have it
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Device Serial Numbers 7021.002073 and 7021.002074
The hazard
According to the FDA, the hazard is the distribution of defibrillators that are not approved or cleared for distribution in the U.S. market.
Context
GovInfoNow's records show Remote Diagnostic Technologies Ltd. has 11 other recalls on record since Nov. 17, 2020. Recent brand recalls include a patient monitor measuring Intracranial Pressure and Bladder Pressure without validated accuracy (Nov. 26, 2025) and a Tempus Pro Patient Monitor software error causing an error screen when attaching a video laryngoscope (April 16, 2025). Other recent recalls of similar products include the Covidien Mon-a-Therm Stethoscope Recall for unapproved temperature sensor risk (April 23, 2026), the MicroPort HIPTURN Fem Head Trial 36mm recalled for no FDA approval for U.S. distribution (Dec. 19, 2025), and Siemens CT Software Applications recalled for unapproved medical software (Dec. 19, 2025).
How to tell if you have this one
Check for the software version 1.3.5 and serial numbers 7021.002073 or 7021.002074 on your Tempus LS defibrillator. The device may also have the UDI code (01)07613365001693.
Brand
Remote Diagnostic Technologies
Product
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Details
Verify the software version and serial numbers on your Tempus LS defibrillator to confirm if it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IL and KS.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Illinois, Kansas.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0861-2022 (January 28, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0861-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.