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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Sequoia Ultrasound Imaging System

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 Class 2 Device Recall ACUSON Sequoia Ultrasound Imaging Systemsee related information
Date Initiated by FirmSeptember 11, 2026
Date PostedNovember 06, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0394-2027
Recall Event ID 99998
510(K)NumberK260844 
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
ProductACUSON Sequoia Ultrasound Imaging System REF: 11148775
Code Information ACUSON Sequoia Origin systems with software version 4.0 (VD10A)
FEI Number 3023245
Recalling Firm/
Manufacturer		 Siemens Medical Solutions USA, Inc.
22010 Se 51st St
Issaquah WA 98029-7298
For Additional Information ContactUltrasound Service Customer Care Center
1800-888-7436
Manufacturer Reason
for Recall		A software issue identified in the ultrasound system may result in the unintended activation of the Color Doppler setting, which has not received FDA clearance. This unintended activation could cause the system to crash or become unresponsive.
FDA Determined
Cause 2		No Marketing Application
ActionOn October 2, 2026, Siemens Healthineers issued a Urgent Medical Device Correction to consignees via E.Mail. Siemens Healthineers ask consignees to take the following actions. 1. To avoid this potential issue, do not modify the Image Preset Editor Cardiac configuration settings without assistance from Siemens Healthineers Clinical Applications personnel. If Color DTI is suspected as being enabled, please contact your Siemens Healthineers Service Customer Care Center. 2. Siemens Healthineers recommends a review of previous examination results ONLY if a clinical assessment was reviewed with the system configured to display the Color DTI mode. 3. Should an adverse event or quality problem be experienced with the use of this product, please report the incident to Siemens Healthineers.
Quantity in Commerce37 systems
DistributionWorldwide - US Nationwide distribution in the states of CA, CT, KY, NC, TX and the countries of Germany, Italy, India.
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 = IYN
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