4Z1c Matrix Array Transducer, model number 10033682, used with ACUSON SC2000 ultrasound systems, model number 10433816, manufactured by Siemens Medical Solutions, Ultrasound Business Unit, Mountain View, CA. The 4Z1c transducer is a special purpose ultrasound transducer designed to help clinicians perform adult echocardiography and pre-operative and intra-operative surgical assessments. Secondary applications include pediatric echocardiography, primarily benefiting older and larger pediatric populations, general abdominal and intra-operative pediatric abdominal imaging and peripheral vessel imaging.
FDA Recall Z-2149-2011 · Posted 2011-05-05
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Date Initiated2009-07-10
Date Terminated2011-05-05
Product Quantity42 units
Reason for Recall
Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.
Firm Action
A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.
Root Cause
Equipment maintenance
Distribution Pattern
Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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