Product Description
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
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.
Action Details
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 ECR.Recall.Response@Philips.com. The following URL can also be used to complete/return the response form: https://philips.efrnfeedback.com/se/705E3ED80E91C689
Distribution Pattern
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.
Code Information / Serial Numbers
00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871
User/Operator Manual Versions: 41-3007EN-01 and prior