Food, drugs, devices › Remote Diagnostic Technologies Ltd.
Device recall: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
FDA enforcement event 89595 is a device recall by Remote Diagnostic Technologies Ltd. of Basingstoke, initiated 28 Jan 2022 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 839 device enforcement events initiated in 2022 carry the same class.
Status: Terminated, terminated 25 Jul 2024. Initiation: voluntary: firm initiated. Remote Diagnostic Technologies Ltd. has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Remote Diagnostic Technologies Ltd., Basingstoke, United Kingdom.
Reason for recall
"Distribution of Defibrillators that are not approved or cleared for distribution US Market."
Distribution
"US Nationwide distribution in the states of IL and KS."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0861-2022 | Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 | 2 | Class II | Terminated | 13 Apr 2022 |
Context
Other enforcement events for Remote Diagnostic Technologies Ltd.
All 12 events for Remote Diagnostic Technologies Ltd.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Distribution of Defibrillators that are not approved or cleared for distribution US Market."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of IL and KS."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 25 Jul 2024. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.