FDA Device recall Z-1010-2022
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only
- FDA Device
- Class II
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class II recall of Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only by Siemens Medical Solutions Usa, citing transducers (component of ultrasound system) may exceed recommended thermal index limits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1010-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-07 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Reason
Transducers (component of ultrasound system) may exceed recommended thermal index limits
Identifiers
| code_info | UDI/DI - (01)4056869243566; Affected Serial Numbers: BT10672 BT10582 BT10617 BT10643 BT10669 BT10580 BT10619 BT10659…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1010-2022%22
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