Philips Tempus LS-Manual Defibrillator, Part Number:… recallZ-2028-2024 · Remote Diagnostic Technologies Ltd. · initiated May 9, 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
Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
FDA root cause category: Labeling design
What the company is doing
On 5/9/24, Philips distributed correction notices to customers and distributors asking them to do the following: 1) The User/Operator Manual was updated can be downloaded by searching "Tempus LS-Manual User-Operator Manual" at Philips.com/IFU 2) 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. 3) Complete and return the response form via email to [email protected]. The following URL can also be used to complete/return the response form: https://philips.efrnfeedback.com/se/705E3ED80E91C689
Recall details
- Recall number
- Z-2028-2024
- Status
- Open, Classified
- Initiated by the company
- May 9, 2024
- Posted by the FDA
- Jun 6, 2024
- Recalling firm
- Remote Diagnostic Technologies Ltd.
- Quantity
- 1745
- Product code
- LDD
- FDA submissions
- K200849
- Distribution
- US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.
Product description
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Code information (models, lots, serial numbers)
00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior
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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