—#84986

Product

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.

510(k) numbers: K072365
Affected lot / code info: seial numbers

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

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

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebird Way P.O. Box 7393, Mountain View, California 94043

Distribution

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

Timeline

Recall initiated: 2009-07-10
Posted by FDA: 2011-05-05
Terminated: 2011-05-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84986. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.