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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Affiniti 70 Diagnostic Ultrasound System

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  Class 2 Device Recall Philips Affiniti 70 Diagnostic Ultrasound System see related information
Date Initiated by Firm October 09, 2023
Date Posted November 09, 2023
Recall Status1 Open3, Classified
Recall Number Z-0284-2024
Recall Event ID 93218
510(K)Number K231190  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Code Information Following serial numbers operating with software version 10.0. Model 795210/UDI: (01)00884838106611/Serial Numbers: US523F1930 US918F1158 US918F1159 US723F1377 US523F1496 US523F1497 US217F0292
Recalling Firm/
Manufacturer		 Philips Ultrasound, Inc.
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Philips Customer Care Solutions Center
1800-722-9377
Manufacturer Reason
for Recall		 Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
FDA Determined
Cause 2		 Software design
Action On October 9, 2023, Philips issued a Urgent Medical Device Correction notification to affected consignees. Philips asked consignees to take the following actions: 1. Identify if your firm has an affected product. 2. In the 2D tab in the system touchscreen, disable the AutoSCAN feature every time a transducer or a Transducer preset is selected to prevent the system from potentially experiencing image lag issue. The AutoSCAN feature is disabled when the button is not highlighted in amber. 3. Please complete and return the attached response form to Philips promptly and no later than 15 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter, understanding of the issue, and required actions to be taken. 4. Circulate this Urgent Medical Device Correction Letter to all users of this device so that they are aware of the issue. Please retain this letter with your system(s) and ensure the letter is in a place likely to be seen/viewed. 5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, or by regular mail, or by fax.
Quantity in Commerce 7 systems
Distribution US: AZ, CA, CT, FL, GA, ID, IL, KY, MD, MT, NE, NV, OH, TN, TX, UT, VA OUS: Canada
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 = IYN and Original Applicant = Philips Ultrasound LLC
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