Siemens Medical Solutions USA, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1010-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: March 7, 2022

Date Posted: May 4, 2022

Recall Number: Z-1010-2022

Event ID: 89856

Reason for Recall:

Transducers (component of ultrasound system) may exceed recommended thermal index limits

Status: Ongoing

Product Quantity: 31 units

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated