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.

This recall has been terminated (originally issued May 5, 2011).

Reason for Recall

Burn risk-- due to coolant leaks, patients may suffer burns or blisters due to increased temperature.

Nationwide. Foreign: Japan, Italy, South Korea, Singapore, Yemen, Germany, Australia, and Greece.

seial numbers

Equipment maintenance

A customer safety advisory notification was sent out to customers on 7/10/09, and a mandatory software update will also be conducted.