FDA Device Recall Z-0557-2025: Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0557-2025.

Recall Res Number

Z-0557-2025

Recalling Firm / Manufacturer

Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom

FEI Number

3003832357

Recall Status

Open, Classified

Recall Classification

N/A

Date Initiated

2024-10-28

Date Posted

2024-11-26

Date Terminated

N/A

Product Code

LDD

Event Number

95642

Product Quantity

N/A

Product Description Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode

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

Action Details 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

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

Code Information / Serial Numbers 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

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Medical Device Recall: Z-0557-2025

Recall Parameters & Description

Related Establishments / Registrations

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