Medical Device Recall: Z-0861-2022

FDA Recalls dataset · Firm: Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom · Status: Terminated

Recall Action Class: N/A Date Initiated: 2022-01-28 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0861-2022.

Recall Res Number
Z-0861-2022
FEI Number
3003832357
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2022-01-28
Date Posted
N/A
Date Terminated
2024-07-25
Product Code
LDD
Event Number
89595
Product Quantity
2
Product Description Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Reason for Recall Distribution of Defibrillators that are not approved or cleared for distribution US Market.
Action Details 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: RDT.Recall.Response@philips.com, - 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.
Distribution Pattern US Nationwide distribution in the states of IL and KS.
Code Information / Serial Numbers Device Serial Numbers 7021.002073 and 7021.002074

Related Establishments / Registrations

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