Z-1010-2022Class II

Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only

Name: Z-1010-2022 Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only
Creator: Siemens Medical Solutions USA, Inc.
Published: 2022-03-07
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2022-03-07 / Open, Classified / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only on 2022-03-07. FDA classified it as Class II and gives the reason as "Transducers (component of ultrasound system) may exceed recommended thermal index limits". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1010-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-03-07
Posted: 2022-04-27
Recalling firm: Siemens Medical Solutions USA, Inc.
Product: Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Product code: IYN System, Imaging, Pulsed Doppler, Ultrasonic
Reason for recall: Transducers (component of ultrasound system) may exceed recommended thermal index limits
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1010-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1010-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-27

Product code IYN

K211859Class IIACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2021-07-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)