Recall Z-0547-2022 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B
| Date | Nov 12, 2021 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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 Emirate |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201462 | ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., Jun 24, 2020 |