Z-1825-2023Class II

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

Name: Z-1825-2023 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Creator: Remote Diagnostic Technologies Ltd.
Published: 2023-05-08
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2023-05-08 / Open, Classified / root cause: design

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 on 2023-05-08. FDA classified it as Class II and gives the reason as "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"". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1825-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-08
Posted: 2023-06-12
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
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".
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 1147
Distribution: US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
Product codes and lots: UDI-DI: 07613365002737. Serial numbers prior to 7022.001634

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1825-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1825-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-21	2023-06-12

Product code LDD

K200849Class IITempus LS - ManualRemote Diagnostic Technologies, Ltd. A Philips Company / cleared 2020-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)