Tempus LS-Manual Defibrillator Model 00-3020 recallZ-0557-2025 · Remote Diagnostic Technologies Ltd. · initiated Oct 28, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Remote Diagnostic Technologies Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
FDA root cause category: Labeling Change Control
What the company is doing
On 10/28/2024, Philips sent an "URGENT Medical Device Correction" Letter via Certified Mail to customers informing them that SCHILLER AG, the manufacturer of the Tempus LS Manual Defibrillator, informed Philips that the incorrect labels were supplied with the service kit (kits 3, 6 and 8). The affected labels can be identified by the wrong device name (TEMPUS LS instead of TEMPUS LS MANUAL), the wrong CAT number (00-3010 instead of 00-3020) and the additional CE marking. SCHILLER AG initiated a correction on 10/07/2024. Customers are instructed to: Share this recall notice with those who need to be aware within their organization and any organization where the potentially affected devices have been transferred. It is recommended that the recall notice be posted on or near affected systems as a constant reminder of the issue until it is corrected. A Philips representative will contact affected customers to arrange for the corrected labels to be affixed to the affected Tempus LS Manual Defibrillators. For questions or assistance, contact Philips at 1-800-722-9377 or email [email protected]
Recall details
- Recall number
- Z-0557-2025
- Status
- Open, Classified
- Initiated by the company
- Oct 28, 2024
- Posted by the FDA
- Nov 26, 2024
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Product code
- LDD
- FDA submissions
- K200849
- Distribution
- U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
Product description
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Code information (models, lots, serial numbers)
Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Tempus LS-MANUAL 3.940589Schiller AG · Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)4 recalls34 deaths391 reports
Other devices under the same FDA submission
1 device cleared under K200849 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Tempus LS-Manual 01-3020Remote Diagnostic Technologies Limited · Dc-Defibrillator, Low-Energy, (Including Paddles)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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