Tempus LS-Manual 01-3020Recalls & reported problems
Remote Diagnostic Technologies Limited · Tempus LS-Manual Adult Electrodes · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05060472441959), received between Apr 30, 2024 and Apr 30, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Peeled/Delaminated” (1 report).
4 other recalls cover devices cleared under the same FDA submission (K200849); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Peeled/Delaminated1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2024Peeled/Delaminated; Peeled/Delaminated
IT HAS BEEN REPORTED THAT POTENTIALLY 220 PADS WERE EXPERIENCING FAULTY ADHESIVE, WHERE THE ADHESIVE WAS STICKING TO THE PROTECTIVE PAPER INSTEAD OF THE PADS. COMPLAINT DATABASE LIMITATIONS PREVENT MORE THAN A QUANTITY OF (B)(4 FROM BEING ADDED AT THIS TIME. PLEASE CONSIDER THE QUANTITY TO BE(B)(4) AS REPORTED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19214282 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K200849. One submission often covers many models, so check the product and lot details in each record.
- Z-0557-2025 · Oct 28, 2024 · Open, ClassifiedTempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
- Z-2028-2024 · May 9, 2024 · Open, ClassifiedPhilips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
- Z-1825-2023 · May 8, 2023 · Open, ClassifiedPhilips Tempus LS-Manual Defibrillator, Part Number: 00-3020
- Z-0564-2021 · Nov 17, 2020 · TerminatedTempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pr
Other Dc-Defibrillator, Low-Energy, (Including Paddles) devices
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall6 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall5 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall1 report
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
- NA 11131Physio-Control, Inc. · Dc-defibrillator, low-energy, (including paddles)1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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