FDAFDA · Food and drugs·Recall number Z-2028-2024
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Published June 12, 2024 · Recall initiated: May 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remote Diagnostic Technologies Ltd.
- Distributor
- 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.
- Lot
- 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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