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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System

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  Class 2 Device Recall Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System see related information
Date Initiated by Firm August 19, 2021
Create Date October 07, 2021
Recall Status1 Open3, Classified
Recall Number Z-0070-2022
Recall Event ID 88625
510(K)Number K201012  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Philips Ultrasound, Inc. Sparq, Diagnostic Ultrasound System, REF 795090, 100-240V -, 50/60 Hz, 500 VA, CE2797, Rx Only,
Code Information Affected Serial Numbers/UDI numbers: USD1410130 /N/A, US12110905 /(01)00884838097971(21)US12110905, US12110906 /(01)00884838097971(21)US12110906, US12111049 /(01)00884838097971(21)US12111049, US31310191 /N/A, US31511242 /N/A, US32111072 /(01)00884838097971(21)US32111072, US41210049 /N/A, US42111774 /(01)00884838097971(21)US42111774, US51210186 /N/A, US62011642 /(01)00884838028098(21)US62011642, US71810505 /(01)00884838028098(21)US71810505, US72011713 /(01)00884838028098(21)US72011713, US72011714 /(01)00884838028098(21)US72011714, US82010111 /(01)00884838028098(21)US82010111, US91410757 /N/A, US92010327 /(01)00884838028098(21)US92010327, US92010512 /(01)00884838028098(21)US92010512, USD2011313 /(01)00884838097971(21)USD2011313, USD2011314 /(01)00884838097971(21)USD2011314, USD2011362 /(01)00884838097971(21)USD2011362, USD2011363 /(01)00884838097971(21)USD2011363, USD2011480 /(01)00884838097971(21)USD2011480, USD2011481 /(01)00884838097971(21)USD2011481, USD2011482 /(01)00884838097971(21)USD2011482, USD2011483 /(01)00884838097971(21)USD2011483, USD2011578 /(01)00884838097971(21)USD2011578, USD2011622 /(01)00884838097971(21)USD2011622, USD2011623 /(01)00884838097971(21)USD2011623, USN1510828 /N/A, USN2011691 /(01)00884838097971(21)USN2011691, USO1210225 /N/A, USO2011257 /(01)00884838097971(21)USO2011257, USO2012052/ (01)00884838097971(21)USO2012052
Recalling Firm/
Manufacturer		 Philips Ultrasound Inc
22100 Bothell Everett Hwy
Bothell WA 98021-8431
For Additional Information Contact Holly Wright Lee
440-483-2015
Manufacturer Reason
for Recall		 Battery system data issue with the ultrasound system can intermittently cause a system shutdown, regardless of actual battery state or application of alternating current power.
FDA Determined
Cause 2		 Software design
Action On August 24, 2021, Philips issued "Urgent Medical device Correction" notification to affected consignees. The customer communication was distributed via: USPS Certified Mail In addition to informing consignees about the recall, Philips requested consignees take the following actions: Instructions for how to determine the software version of your Ultrasound system: 1. Power up the system and allow it to complete the boot sequence, 2. Press the Wrench icon on the upper right side of the control panel, 3. Press the Service button on the bottom left corner, 4. Under System Management, Press System Information, 5. The software version is listed in the Software Information Section. 4. Describe the actions that should be taken by the customer / user in order to prevent risks for patients or users A. If this shutdown occurs, Philips recommends that the system be put back on AC power and restarted. The system will be fully functional upon restart. However, restarting the system will not prevent the possibility of the issue reoccurring. B. Please complete and return the attached form to Philips promptly and no later than 30 days from receipt (via email: ultrasound.corrections@philips.com, or fax: 1-833-512-7756). 5. Describe the actions planned by Philips Ultrasound to correct the problem A Philips Field Service Engineer will contact you to schedule a software update to permanently resolve the issue (reference FCO79500550). 6. This notice has been reported to the appropriate Regulatory Agencies. 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. 7. Please be assured that maintaining a high level of safety and quality is our highest priority. If you need any further information or support concerning this issue, please contact your local Philips representative: 1-800-722-9377 and reference FCO79500550.
Quantity in Commerce 34 units
Distribution Worldwide distribution - US Nationwide distribution in the states of CA, MA, MD, MI, MS, NC, NY, OH, VA, WA and the countries of Australia, Portugal, Netherlands, Canada, Netherlands, Germany.
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, Inc.
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