| Class 2 Device Recall ACUSON Sequoia Ultrasound Imaging System | |
Date Initiated by Firm | November 12, 2021 |
Create Date | February 03, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0547-2022 |
Recall Event ID |
89139 |
510(K)Number | K201462 |
Product Classification |
System, imaging, pulsed doppler, ultrasonic - Product Code IYN
|
Product | ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B |
Code Information |
Software Version VA25A/B
System Serial Numbers:
800101
800106
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|
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 22010 SE 51st St Issaquah WA 98029-7298
|
For Additional Information Contact | Siemens Healthineers USD Complaints 425-392-9180 |
Manufacturer 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. |
FDA Determined Cause 2 | Software design |
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 usd-complaint.team@siemens-healthineers.com |
Quantity in Commerce | 1161 systems |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = IYN
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