Recall Z-1330-2021 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Product Label - ACUSON Sequoia *** Power Input: 100-240V~, 13.0-5.4A, 50-60Hz *** (240)11148775 Model User Manual states - ACUSON Sequoia Diagnostic Ultrasound Systems
| Date | Feb 4, 2021 |
| Status | Open, Classified |
| Reason | The ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD, which may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births. |
| Root cause | Software Design Change |
| Action | On 02/04/2021, the firm sent an "CUSTOMER SAFETY ADVISORY NOTIFICATION" email to customer informing them that the ultrasound system averages the Mean Sac Diameter (MSD) and Gestational Sac Diameter (GSD) into the Estimated Date of Delivery (EDD) calculation. This may result in an incorrect EDD. An incorrect EDD may influence patient management decisions regarding induction of labor and elective caesarean delivery, which may result in premature births. -Customers are instructed to avoid this issue, delete any MSD or GSD values from the patient report if other biometric parameters are measured. |
| Quantity | 1,172 systems |
| Distribution | U.S.: AK, AL, AR, AZ, CA, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY O.U.S.: U.A.E., Algeria, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193257 | ACUSON Sequoia Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., Jan 31, 2020 |