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Terminated

ACUSON S Family Ultrasound Systems at software versions VC25D, VC30A and VC30B; (S2000, S3000 and S1000 systems) Siemens Medical Solutions USA, Inc. Ultrasound imaging systems.

FDA Recall Z-1962-2014 · Posted 2014-07-01

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2014-06-03
Date Terminated2016-05-25
Product Quantity790 units

Reason for Recall

There is a potential measurement error with the Auto-Stats (auto statistics) measurement tool on the ACUSON S Family ultrasound system.

Firm Action

Siemens sent a Customer Safety Advisory Notification letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: To avoid the potential risk of this issue, do not use the Auto-Stats tool; use alternate measurement tools. Only use the Velocity tool on frozen images. Customer Service Engineer will contact the customer to schedule an appointment to replace their existing version of software, free of charge. Customers with questions should contact their local service support person for information regarding timelines and status. Customers were instructed to share this information with all personnel within their organization who need to be aware of this issue. For questions regarding this recall call 650-694-5135.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution - USA including CA, MO, VA, PA, WV, and Internationally to Angola, Argentina, Australia, Austria, Belarus, Belgium, Bolivia, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Dominican Rep., Ecuador, Egypt, France, Germany, Greece, India, Iraq, Israel, Italy, Japan, Kazakhstan, Malaysia, Mexico, Morocco, Netherlands, Norway, P.R. China, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, U.A.E., Ukraine, United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K132804ACUSON S1000 / S2000 / S3000Siemens Medical Solutions USA, Inc. Ultrasound Gro · 2013-10-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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