Device product

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

Z-1010-2022

March 07, 2022

Class II

Product summary

Firm: Siemens Medical Solutions USA, Inc.
Event: Event 89856
Status: Ongoing
Classification: Class II
Quantity: 31 units
Official record key: device-enforcement:Z-1010-2022

Official wording

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

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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