—#84555

Product

Siemens ACUSON X300 Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795) Product is an ultrasound imaging system intended for General Radiology,Fetal, Abdominal, Intaoperatve, Pediatric, Small parts, Neunatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and peripheral Vascular Applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes. The Arterial Health Package software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published with peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system. The V5Ms is a multifrequency,multi-plane, phased sector array transducer, which can be introduced into the esophagus to obtain heart structure images. Transesophageal echocardiography is used to obtain unobstructed views of the heart surrounding tissue.

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K072676
Affected lot / code info: Premium Edition Systems with software versions 5.0.00 and 5.0.01 (model numbers 10348531, 10348532 and 10348533), when using the V5Ms transducer (model number 08263703) and the Plus option (10427795)

Why it was recalled

Product Failure-- When the 64-Channel System V5M is used in the 128-Channel mode, an over current fault occurs which shuts the system down.

Root cause (FDA determination)

Software design

Action the firm took

Siemens sent a Customer Safety Advisory Notification letter on July 24, 2009. The letter identified the product, the problem, and the action to be taken by the customer. A software update will be conducted in the field. Until that update occurs, customers were instructed to image without the CW doppler to avoid a system shut down. Customers were instructed to contact their service support person with any questions. For questions regarding this recall call 650-694-5993.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA including CA, CT, FL, MA, and TX and the countries of United Arab Emirates, Germany, Ecuador, Spain, France, Great Britian, Saudi Arabia, Sweden, Thailand, and South Africa.

Timeline

Recall initiated: 2009-07-24
Posted by FDA: 2011-04-25
Terminated: 2011-04-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #84555. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.