Z-1010-2022 Class II Ongoing
FDA device recall Z-1010-2022 was initiated by Siemens Medical Solutions USA, Inc. on Mar 7, 2022 and is designated Class II. Reason for recall: Transducers (component of ultrasound system) may exceed recommended thermal index limits The recall status is ongoing. Affected quantity: 31 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 4, 2022
- Initiation Date
- Mar 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31 units
Product Description
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Reason for Recall
Transducers (component of ultrasound system) may exceed recommended thermal index limits
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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1010-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026