Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Recall
- Recall Number
- Z-1825-2023
- Event Number
- 92251
- Firm
- Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom
- FEI Number
- 3003832357
- Product Code
- LDD
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- May 8, 2023
- Posted
- June 12, 2023
Description
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
On 5/8/23, Philips mailed correction notices to customers who were asked to do the following: Potential risks associated with partial or complete failure of the device, should a patient be involved, will be mitigated by immediately starting CPR/ chest compressions in case of device dysfunction/failure. Philips will contact to arrange for the device to be returned for rework. A loner device will be provided during the time of the rework. 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. Complete and return the Customer/Distributor Reply Form: https://philips.efmfeedback.com/se/705E3ED8496AFDF8/ https://philips.efmfeedback.com/se/705E3ED8496AFDF8 Customers/Distributors who need further information or support can contact [email protected], or 1 800 722 9377 In addition, distributors were asked to forward the correction notice to their customers. The notice should be modified to include the distributor's contact information.
US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
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