Siemens Medical Solutions USA, Inc. Recall 89856
Description: Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Siemens Medical Solutions USA, Inc. Recall 89856 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1010-2022 |
| Event ID | 89856 |
| Event Description | Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only , |
| Product Type | Devices |
| 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. |
| Quantity | 31 units |
| Recall Reason | Transducers (component of ultrasound system) may exceed recommended thermal index limits |
| Device Classification | 20220504 |
| Device 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 |
| Center Classification Date | 20220427 |
| Recall Initiation Date | 20220307 |
| Recalling Firm | Siemens Medical Solutions USA, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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