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U.S. Department of Health and Human Services

Class 2 Device Recall Tempus LSManual

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  Class 2 Device Recall Tempus LSManual see related information
Date Initiated by Firm May 08, 2023
Date Posted June 12, 2023
Recall Status1 Open3, Classified
Recall Number Z-1825-2023
Recall Event ID 92251
510(K)Number K200849  
Product Classification Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
Product Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Code Information UDI-DI: 07613365002737. Serial numbers prior to 7022.001634
Recalling Firm/
Manufacturer		 Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough United Kingdom
For Additional Information Contact Philips Customer Services
800-722-9377
Manufacturer Reason
for Recall		 Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error message "HW failure DPM".
FDA Determined
Cause 2		 Device Design
Action On 5/8/23, Philips mailed correction notices to customers who were asked to do the following: Potential risks associated with partial or complete failure of the device, should a patient be involved, will be mitigated by immediately starting CPR/ chest compressions in case of device dysfunction/failure. Philips will contact to arrange for the device to be returned for rework. A loner device will be provided during the time of the rework. 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. Complete and return the Customer/Distributor Reply Form: https://philips.efmfeedback.com/se/705E3ED8496AFDF8/ https://philips.efmfeedback.com/se/705E3ED8496AFDF8 Customers/Distributors who need further information or support can contact RDT.Recall.Response@Philips.com, or 1 800 722 9377 In addition, distributors were asked to forward the correction notice to their customers. The notice should be modified to include the distributor's contact information.
Quantity in Commerce 1147
Distribution US Nationwide distribution in the states of UT, CO, CA, NE, IL, TX, WV, KS, GA.
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.
510(K) Database 510(K)s with Product Code = LDD and Original Applicant = Remote Diagnostic Technologies, Ltd, a Philips Company
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