Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020

FDA device recall Z-1825-2023 · posted 2023-06-12 · Open, Classified

Recall details

Recalling firm

Remote Diagnostic Technologies Ltd.

Reason for recall

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".

Action taken

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 RDT.Recall.Response@Philips.com, 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.

Root cause

Device Design

Status

Open, Classified

Product code

LDD

Quantity affected

1147

Distribution

US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.

Date initiated

2023-05-08

Date posted

2023-06-12

Location

Farnborough, United Kingdom

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