Z-2028-2024Class II

Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual

Name: Z-2028-2024 Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Creator: Remote Diagnostic Technologies Ltd.
Published: 2024-05-09
License: https://open.fda.gov/license/

Remote Diagnostic Technologies Ltd. / initiated 2024-05-09 / Open, Classified / root cause: labeling and UDI

FDA source

Remote Diagnostic Technologies Ltd. began a recall of Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual on 2024-05-09. FDA classified it as Class II and gives the reason as "Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may...". 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-2028-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-09
Posted: 2024-06-06
Recalling firm: Remote Diagnostic Technologies Ltd.
Product: Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Product code: LDD Dc-Defibrillator, Low-Energy, (Including Paddles)
Reason for recall: Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 5/9/24, Philips distributed correction notices to customers and distributors asking them to do the following: 1) The User/Operator Manual was updated can be downloaded by searching "Tempus LS-Manual User-Operator Manual" at Philips.com/IFU 2) 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. 3) Complete and return the response form via email to [email protected]. The following URL can also be used to complete/return the response form: https://philips.efrnfeedback.com/se/705E3ED80E91C689
Quantity in commerce: 1745
Distribution: US Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.
Product codes and lots: 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2028-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2028-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-12	2024-06-06

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)