Food, drugs, devices › Remote Diagnostic Technologies Ltd.
Device recall: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Remote Diagnostic Technologies Ltd. (Farnborough, N/A) initiated this device recall on 8 May 2023; FDA lists 1 product record under event 92251, classified Class II.
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 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. 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., Farnborough, N/A, United Kingdom.
Reason for recall
"Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM"."
Distribution
"US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1825-2023 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 | 1147 | Class II | Ongoing | 21 Jun 2023 |
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: "Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM"."
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 UT, CO, CA, NE, IL, TX, WV, KS, GA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.