Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

FDA Recall Z-0547-2022 · Posted None

Recalling FirmSiemens Medical Solutions USA, Inc.
Recall StatusOpen, Classified
Product CodeIYN
Date Initiated2021-11-12
Product Quantity1161 systems

Reason for Recall

Due to a calculation error in the measurement when using 2D trace (manual trace) tool. The trace circumference value is overestimated and may potentially result in misdiagnosis of a patient's condition.

Firm Action

On 11/12/2021, the firm sent a "MEDICAL DEVICE SAFETY CORRECTION" Letter via email and certified US Post to inform customers that within their ultrasound system there is a calibration error in the measurement when using the 2D trace (manual trace) tool. the trace circumference value is overestimated, however, the area value is accurate. Customers are instructed: -To avoid overestimation of circumference measurements, use the default ellipse tool for all circumference measurements. -To avoid overestimation of distance measurements, use default distance tool for all distance measurements. The Recalling Firm will correct this issue with a free-of-charge update to affected ultrasound systems with a new software version. Customer will be contacted by a service engineer to schedule a facility visit to update the system or inform them of a remote update. For questions, send any inquires to: Siemens Healthineers USD Complaints at [email protected]

Root Cause

Software design

Distribution Pattern

Worldwide distribution - U.S. Nationwide distribution in the states of AL, AK, AZ, AR, CA, CO, CN, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, MD, MI, MN, MS, MO, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WV, WI, and WY. The countries of United Arab Emirates, Armenia, Angola, Austria, Australia, Azerbaijan, Bangladesh, Belgium, Bahrain, Brazil, Switzerland, Chile, China, Colombia, Cyprus, Czech Republic, Germany, Denmark, Dominican Rep., Egypt, Spain, Finland, France, United Kingdom, Georgia, Greece, Guatemala, Hong Kong, Croatia, Indonesia, Israel, Iceland, Italy, Japan, Republic Korea, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Serbia, Russian Fed., Saudi Arabia, Sweden, Singapore, Slovakia, Thailand, Turkey, Taiwan, Ukraine, South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K201462ACUSON Sequoia Diagnostic Ultrasound SystemSiemens Medical Solutions USA, Inc. · 2020-06-24

Official Source

View FDA Recall →

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

↑