Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
FDA device recall Z-1010-2022 · posted 2022-04-27 · Open, Classified
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Transducers (component of ultrasound system) may exceed recommended thermal index limits
- Action taken
- 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
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- IYN
- Quantity affected
- 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, Fr
- Date initiated
- 2022-03-07
- Date posted
- 2022-04-27
- Location
- Issaquah, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON Sequoia Diagnostic Ultrasound System (K211859) | Siemens Medical Solutions USA, Inc. | 2021-07-20 |