Remote Diagnostic Technologies Ltd.: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

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.

Details from the source

Reason for recall: 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. 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. Quantity: 1745 Lot/code info: 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior

UPC codes

07613365002737

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.