—#73272

Product

Siemens Ultrasound, Acuson/Sonovista X300 ultrasound systems, software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02, manufactured by Siemens Ultrasound

FDA product code: IYN — System, Imaging, Pulsed Doppler, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072676
Affected lot / code info: Sonovista: 10133170, Acuson: 10037409 (potentially affected but no volume: 10132987, 10038837). Software revisions 2.0.1 to 2.0.05, 3.0.01 and 3.0.02

Why it was recalled

Thermal Index cranial (TIC) is not displayed for the Neo-Head exam type with the C8-5 transducer. This is a required display to support the alara principle when imaging cranial structure.

Root cause (FDA determination)

Employee error

Action the firm took

Field correction was initiated on 8/19/2008. Under Siemens update program US020/08/S & US021/08/S Siemens service personnel make a site visit, deliver a customer safety advisory notice to the customer and correct the problem by installing the revised Software versions. After the planned field correction is performed at the customer site the Service personnel log that information through Siemens internal web or reporting tools into the Siemens field update database.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution --- including USA and countries of France, Colombia, Poland, Taiwan, Saudi Arabia, Austria, Malaysia, India, Czech Republic, Croatia, Argentina, Venezuela, Italy, Philippines, Mauritius, Spain, Bolivia, Germany, Ukrain, Russia, United Kingdom, Brazil, South Africa and Canada.

Timeline

Recall initiated: 2008-08-19
Posted by FDA: 2008-10-10
Terminated: 2010-12-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #73272. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.