CLASS II Device recall · Reported 13 Apr 2022 · FDA Enforcement Report
Tempus LS, Type DGE1, CAT recalled by Remote Diagnostic Technologies
Remote Diagnostic Technologies is recalling Tempus LS, Type DGE1, CAT 00-3010, distributed nationwide in the US. The recall was initiated on 28 Jan 2022 and the FDA has classified it as Class II.
Check your package
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-0861-2022
- FDA event ID
- 89595
- Recalling firm
- Remote Diagnostic Technologies, Basingstoke
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Jan 2022
- FDA classified
- 4 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Hidden Drug Ingredients
- Device type
- Medical Software
Timeline
| 28 Jan 2022 | Recall initiated by company | |
| 4 Apr 2022 | Classified by FDA | +66 days |
| 13 Apr 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Where it was distributed
US Nationwide distribution in the states of IL and KS.
Questions about this recall
Why was it recalled?
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Which lots are affected?
Device Serial Numbers 7021.002073 and 7021.002074
Where was it sold?
US Nationwide distribution in the states of IL and KS.
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 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
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|---|---|---|---|---|---|
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Other | Nationwide |
| Device | CLASS II | Inseego USB8 Dongle Kit recalled by Remote Diagnostic Technologies | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS II | Philips Tempus Pro Patient Monitor recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
| Device | CLASS II | Tempus Pro Patient Monitor, REFs recalled | Remote Diagnostic Technologies | Device Malfunction | Nationwide |
| Device | CLASS III | Tempus LS-Manual Defibrillator recalled | Remote Diagnostic Technologies | Labeling Errors | Nationwide |
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