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U.S. Department of Health and Human Services

Class 2 Device Recall Tempus LS

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  Class 2 Device Recall Tempus LS see related information
Date Initiated by Firm January 28, 2022
Create Date April 04, 2022
Recall Status1 Open3, Classified
Recall Number Z-0861-2022
Recall Event ID 89595
Product Classification Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
Product Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Code Information Device Serial Numbers 7021.002073 and 7021.002074
Recalling Firm/
Manufacturer		 Remote Diagnostic Technologies Ltd.
PAVILION C2, ASHWOOD PARK
ASHWOOD WAY
Basingstoke United Kingdom
Manufacturer Reason
for Recall		 Distribution of Defibrillators that are not approved or cleared for distribution US Market.
FDA Determined
Cause 2		 No Marketing Application
Action 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.
Quantity in Commerce 2
Distribution US Nationwide distribution in the states of IL and KS.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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