Recall Z-1600-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 Diagnostic Ultrasound System, REF: 11503314, running software version VA10A to VA10G
| Date | Apr 19, 2024 (initiated Feb 23, 2024) |
| Status | Open, Classified |
| Reason | On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions. |
| Root cause | Software design |
| Action | On 2/23/24, correction notices were sent to customers informing them of the following: This issue is specific to and limited to the use of the Cardiac DICOM SR feature: - When a user uses and configures the Cardiac DICOM SR feature to display either the MINIMUM (Min) or the MAXIMUM (Max) measured value, AND - Makes multiple measurements of the cardiac region during an examination, AND - Exports the results into the Cardiac DICOM SR feature, THEN - The Cardiac DICOM SR viewer will NOT display the MINIMUM (Min) or MAXIMUM (Max) value and will instead display the LAST measured value. In that case |
| Quantity | 628 |
| Distribution | Worldwide distribution - US Nationwide including in the states of AL, AR, CA, CO , CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA , MD, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PR, RI, SD, TN, TX, UT, VA, WA, WI, WY and the countries of BG, BW, BA, TR, AR, CL, CN, FR, SK, CD, BH, PH, AM, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K210743 | ACUSON Redwood Diagnostic Ultrasound System Siemens Medical Solutions USA, Inc., Apr 1, 2021 |