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 Recall Z-2061-2011 · Posted 2011-04-25
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Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYO
Date Initiated2009-07-24
Date Terminated2011-04-25
Product Quantity70 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Software design
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.
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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