Recall Z-2028-2024 ยท LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
| Date | Jun 6, 2024 (initiated May 9, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Labeling design |
| 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 ECR.Recall.Response@Philips.com. The following URL can also be used to complete/return the response form: https://philips.efrnfee |
| Quantity | 1745 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K200849 | Tempus LS - Manual Remote Diagnostic Technologies, Ltd. A Philips Company, Jul 24, 2020 |