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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 LSManualsee related information
Date Initiated by FirmMay 09, 2024
Date PostedJune 06, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2028-2024
Recall Event ID 94618
510(K)NumberK200849 
Product Classification Dc-defibrillator, low-energy, (including paddles) - Product Code LDD
ProductPhilips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Code Information 00-3020: UDI-DI-07613365002737, Serial Numbers prior to 7022.002871 User/Operator Manual Versions: 41-3007EN-01 and prior
Recalling Firm/
Manufacturer		 Remote Diagnostic Technologies Ltd.
Farnborough Aerospace Centre
Aerospace Boulevard
Farnborough United Kingdom
For Additional Information ContactPhilips Customer Services
800-7229377
Manufacturer Reason
for Recall		Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or interference, which may lead to distortions of the ECG signal; distortions may lead to no or ineffective pacing, or no or inappropriate defibrillation pulse.
FDA Determined
Cause 2		Labeling design
ActionOn 5/9/24, Philips distributed correction notices to customers and distributors asking them to do the following: 1) The User/Operator Manual was updated can be downloaded by searching "Tempus LS-Manual User-Operator Manual" at Philips.com/IFU 2) 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. 3) Complete and return the response form via email to ECR.Recall.Response@Philips.com. The following URL can also be used to complete/return the response form: https://philips.efrnfeedback.com/se/705E3ED80E91C689
Quantity in Commerce1745
DistributionUS Nationwide distribution including in the states of VA, DC, MA, WY, AZ, FL, CA, NM, NJ, TN, OH, KS, IN, NY, IL, TX, NV, NE, PA, AL, IA, GA, MO, KY, WI, OR, CO, WV, WA, ET, UT, ID, OK, MN, ME, MT, MI, NC, ND, MD, DE, VT.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LDD
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