FDA-Device2024-06-12Class II
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Remote Diagnostic Technologies Ltd.
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.
Sold states
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.
Affected count
1745
Manufactured in
Farnborough Aerospace Centre, Aerospace Boulevard, Farnborough, N/A, United Kingdom
Products
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2028-2024Don't want to check this manually?
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