Z-0861-2022Class II

Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693

Name: Z-0861-2022 Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Creator: Remote Diagnostic Technologies Ltd.
Published: 2022-01-28
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2022-01-28 / Terminated

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693 on 2022-01-28. FDA classified it as Class II and gives the reason as "Distribution of Defibrillators that are not approved or cleared for distribution US Market". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0861-2022
Classification: Class II
Status: Terminated
Initiated: 2022-01-28
Posted: 2022-04-04
Terminated: 2024-07-25
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: Distribution of Defibrillators that are not approved or cleared for distribution US Market.
FDA root cause: No Marketing Application
Action: On January 31, 2022 , Remote Diagnostic initiated notified customer about the recall device via email. Remote Diagnostic issued a "Urgent Medical Device Recall" notification on February 18, 2022 to affected consignees. In addition, to informing consignees about the recalled product, the Remote Diagnostic asked consignees to take the following actions: 1. Arrangements have been made by Philips SPS (Spare Parts Supply Chain) to have the devices returned to Philips and for the devices to be replaced with the correct model of devices, i.e. Tempus LS-Manual (Part Number 00-3020) 2. If you need any further information or support concerning this issue, please contact your local Philips representative - Email: [email protected], - Phone: 1 (800) 7222-9377/ +44 (0) 1256 362400 3. Please complete and return this form to Philips promptly upon receipt and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Recall Letter, understanding of this issue, and required action to be taken.
Quantity in commerce: 2
Distribution: US Nationwide distribution in the states of IL and KS.
Product codes and lots: Device Serial Numbers 7021.002073 and 7021.002074

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0861-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0861-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-13	2022-04-04

Product code LDD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)