Recall archive / FDA device enforcement
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , — FDA record Z-1010-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
- Reason
- Transducers (component of ultrasound system) may exceed recommended thermal index limits
- Classification
- Class II
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Quantity
- 31 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1010-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
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.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 4, 2022
- Recall initiation date
- Mar 7, 2022
- Center classification date
- Apr 27, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.