Siemens Medical Solutions USA, Inc.: Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,

Is my product affected?

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

• UPC 4056869243566

Check against the official notice below — it lists the full affected range.

What happened

Siemens Medical Solutions USA, Inc. is recalling 31 Acuson 9vE4 Transducers (Model 240)11289564 CE0129 that were distributed worldwide, including in the US states of Washington, Alaska, Ohio, South Carolina, Pennsylvania, Arizona, New York, and Texas, as well as in Australia, Czech Republic, France, United Kingdom, Indonesia, Mexico, and New Zealand. The transducers, which are components of ultrasound systems, may exceed recommended thermal index limits.

The affected transducers have specific serial numbers ranging from BT00248 to BT10673, and are identified by UDI/DI (01)4056869243566. The recall source does not specify a remedy or recommended course of action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Transducers (component of ultrasound system) may exceed recommended thermal index limits 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 Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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