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U.S. Department of Health and Human Services

Class 2 Device Recall Acuson 9VE4 Tranducer

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  Class 2 Device Recall Acuson 9VE4 Tranducer see related information
Date Initiated by Firm March 07, 2022
Date Posted April 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1010-2022
Recall Event ID 89856
510(K)Number K211859  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Code Information UDI/DI - (01)4056869243566; Affected Serial Numbers: BT10672 BT10582 BT10617 BT10643 BT10669 BT10580 BT10619 BT10659 BT10611 BT10612 BT10614 BT10673 BT10581 BT10494 BT10610 BT10641 BT10497 BT10615 BT10661 BT10667 BT00248 BT10613 BT10657 BT10640 BT10584 BT10488 BT10481 BT10644
Recalling Firm/
Siemens Medical Solutions USA, Inc.
22010 SE 51st St
Issaquah WA 98029-7298
For Additional Information Contact Customer Care Center
Manufacturer Reason
for Recall
Transducers (component of ultrasound system) may exceed recommended thermal index limits
FDA Determined
Cause 2
Process control
Action On 4/1/22, Siemens issued a "Urgent Medical Device Safety Correction" via: email to affected consignees. Prior to receiving the email the firm's representatives contacted consignees by phone or by visit to inform them of the recall. In addition, to providing consignees with information on the recalled product, Siemens asked consignees to take the following actions: Immediately stop performing procedures using the ACUSON 9VE4 transducer and segregate the product. Please ensure that all users of the affected transducer within your organization, and others who may need to be informed, receive the safety relevant information provided with this notice and take the actions specified herein. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Medical Device Safety Correction. To acknowledge receipt of this notice, you must DIGITALLY SIGN it by clicking on the link provided in the email where this notice was attached. By digitally signing this document, you are acknowledging that you have read and understand the content of this Urgent Medical Device Safety Correction. If an adverse event or quality problem is experienced with the use of this product, the issue may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Siemens will correct the issue with a free-of-charge replacement ACSUON 9VE4 transducer. If you haven't been contacted yet, siemens representative will call to schedule a time to document and retrieve the transducer that was removed from service
Quantity in Commerce 31 units
Distribution Worldwide distribution - US Nationwide distribution in the states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, Texas and the countries of Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, New Zealand.
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 = Siemens Medical Solutions USA, Inc