Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
- Recall Initiated
- March 7, 2022
- Posted
- April 27, 2022
- Recall Number
- Z-1010-2022
- Quantity
- 31 units
- Firm Location
- Issaquah, WA
Reason for Recall
Transducers (component of ultrasound system) may exceed recommended thermal index limits
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.
Lot / Code Info
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
Root Cause
Process control
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