Recall Z-2028-2024
Remote Diagnostic Technologies Ltd. · initiated May 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Codes / lots: 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior
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.
FDA-determined cause: Labeling design
Action taken
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
Details
- Recall number
- Z-2028-2024
- Initiated
- May 9, 2024
- Posted by FDA
- June 6, 2024
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- 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.
- Recalling firm
- Remote Diagnostic Technologies Ltd., Farnborough