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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

Mandated?Voluntary: Firm initiated
Recall NumberZ-1010-2022
Event ID89856
Event DescriptionAcuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Product TypeDevices
DistributionWorldwide 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.
Quantity31 units
Recall ReasonTransducers (component of ultrasound system) may exceed recommended thermal index limits
Device Classification20220504
Device Code InfoUDI/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 Date20220427
Recall Initiation Date20220307
Recalling FirmSiemens Medical Solutions USA, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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