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Terminated

ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

FDA Recall Z-2314-2015 · Posted 2015-07-29

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusTerminated
Product CodeIYN
Date Initiated2015-06-25
Date Terminated2017-10-19
Product Quantity1789 units

Reason for Recall

Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis.

Firm Action

Customer Safety Advisory notifications were sent by certified mail to US customers on June 25, 2015. Siemens Service organization coordinate the implementation of the field correction with the distributors for all countries. Letters advised users of the potential miscalculation on ACUSON S1000, ACUSON S2000, or ACUSON S3000 ultrasound systems with software version VC30A, VC30B, VC30C, or VC31A. The manual trace tool may incorrectly calculate the Time Average Velocity and subsequently incorrectly calculate the Pulsatility index. This could lead to potential misdiagnosis. To mitigate the problem users should not perform measurement utilizing the manual Doppler trace tool in a full screen display format. This issue will be resolved in a future software release. If you have any questions, please contact your Siemens Service for more information. Until the necessary repairs have been completed on your system, please share this information with all personnel within your organization who need to be aware of this issue. Siemens is continuing to ship in forward production and will be including the customer safety advisory notice with the shipment. Siemens will update the software for those customers as well once it is released. For further questions please call (650) 694-5398.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Dem. Rep. Congo, Denmark, Dominican Rep., Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Lebanon, Malaysia, Mexico, Morocco, Nepal, Netherlands, New Zealand, Norway, P.R. China, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Russian Fed., Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Trinidad,Tobago, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Uzbekistan, Venezuela and Vietnam.

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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