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U.S. Department of Health and Human Services

Class 2 Device Recall ACUSON Sequoia Ultrasound Imaging System

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  Class 2 Device Recall ACUSON Sequoia Ultrasound Imaging System see related information
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 800117 800126 800135 800136 800138 800140 800142 800147 800157 800159 800162 800163 800171 800176 800177 800181 800182 800183 800184 800185 800186 800187 800190 800191 800192 800196 800199 800203 800205 800206 800207 800211 800212 800213 800218 800219 800220 800223 800225 800226 800228 800229 800230 800232 800236 800237 800241 800244 800249 800250 800251 800255 800256 800258 800260 800265 800267 800273 800275 800278 800279 800281 800285 800286 800288 800290 800291 800292 800294 800295 800302 800304 800305 800314 800315 800319 800328 800334 800335 800338 800339 800341 800346 800356 800357 800360 800362 800368 800369 800371 800375 800383 800388 800390 800391 800397 800399 800405 800406 800408 800411 800426 800428 800433 800435 800436 800439 800449 800451 800454 800458 800463 800464 800466 800467 800468 800472 800473 800474 800483 800490 800517 800530 800532 800535 800545 800549 800551 800555 800557 800559 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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
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.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = Siemens Medical Solutions USA, Inc
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