Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 recallZ-1825-2023 · Remote Diagnostic Technologies Ltd. · initiated May 8, 2023
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
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".
FDA root cause category: Device Design
What the company is doing
On 5/8/23, Philips mailed correction notices to customers who were asked to do the following: Potential risks associated with partial or complete failure of the device, should a patient be involved, will be mitigated by immediately starting CPR/ chest compressions in case of device dysfunction/failure. Philips will contact to arrange for the device to be returned for rework. A loner device will be provided during the time of the rework. This notice needs to be shared with those who need to be aware within your organization and any organization where the potentially affected devices have been transferred. Complete and return the Customer/Distributor Reply Form: https://philips.efmfeedback.com/se/705E3ED8496AFDF8/ https://philips.efmfeedback.com/se/705E3ED8496AFDF8 Customers/Distributors who need further information or support can contact [email protected], or 1 800 722 9377 In addition, distributors were asked to forward the correction notice to their customers. The notice should be modified to include the distributor's contact information.
Recall details
- Recall number
- Z-1825-2023
- Status
- Open, Classified
- Initiated by the company
- May 8, 2023
- Posted by the FDA
- Jun 12, 2023
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Quantity
- 1147
- Product code
- LDD
- FDA submissions
- K200849
- Distribution
- US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
Product description
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Code information (models, lots, serial numbers)
UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
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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