Z-0557-2025Class III

Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock...

Name: Z-0557-2025 Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock...
Creator: Remote Diagnostic Technologies Ltd.
Published: 2024-10-28
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2024-10-28 / Open, Classified / root cause: labeling and UDI

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode on 2024-10-28. FDA classified it as Class III and gives the reason as "Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0557-2025
Classification: Class III
Status: Open, Classified
Initiated: 2024-10-28
Posted: 2024-11-26
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: On 10/28/2024, Philips sent an "URGENT Medical Device Correction" Letter via Certified Mail to customers informing them that SCHILLER AG, the manufacturer of the Tempus LS Manual Defibrillator, informed Philips that the incorrect labels were supplied with the service kit (kits 3, 6 and 8). The affected labels can be identified by the wrong device name (TEMPUS LS instead of TEMPUS LS MANUAL), the wrong CAT number (00-3010 instead of 00-3020) and the additional CE marking. SCHILLER AG initiated a correction on 10/07/2024. Customers are instructed to: Share this recall notice with those who need to be aware within their organization and any organization where the potentially affected devices have been transferred. It is recommended that the recall notice be posted on or near affected systems as a constant reminder of the issue until it is corrected. A Philips representative will contact affected customers to arrange for the corrected labels to be affixed to the affected Tempus LS Manual Defibrillators. For questions or assistance, contact Philips at 1-800-722-9377 or email [email protected]
Distribution: U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.
Product codes and lots: Model Number: 00-3020 UDI-DI code: 07613365002737 Serial Numbers: 7022.000367 7022.000387 7022.000392 7022.000462 7022.000463 7022.000464 7022.000559 7022.000591 7022.000595 7022.000711 7022.000781 7022.000786 7022.00108 7022.001175 7022.001201 7022.00129 7022.001556 7022.001582

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0557-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0557-2025	Class III	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-26

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)