Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
FDA Recall Z-2028-2024 · Posted 2024-06-06
Advertisement
Recalling FirmRemote Diagnostic Technologies Ltd.
Recall StatusOpen, Classified
Product CodeLDD
Date Initiated2024-05-09
Product Quantity1745
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.
Firm Action
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
Root Cause
Labeling design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement