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

FDA device recall Z-0557-2025 · posted 2024-11-26 · Open, Classified

Recall details

Recalling firm

Remote Diagnostic Technologies Ltd.

Reason for recall

Due to incorrect labels applied to devices during servicing. Labels contain the incorrect product name and CAT number.

Action taken

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 ECR.Recall.Repsonse@Philips.com

Root cause

Labeling Change Control

Status

Open, Classified

Product code

LDD

Distribution

U.S. Nationwide distribution in the states of AL, CA, FL, MO, NY, OH, TX and VA.

Date initiated

2024-10-28

Date posted

2024-11-26

Location

Farnborough, United Kingdom

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