Recall Z-3216-2024 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Redwood 1.0 and 2.0 Diagnostic Ultrasound Systems, REF: 11503314, with software
| Date | Sep 24, 2024 (initiated Aug 15, 2024) |
| Status | Open, Classified |
| Reason | If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management |
| Root cause | Software design |
| Action | On 8/15/2024, correction notices were distributed to customers who were asked to do the following: To avoid potential misdiagnosis by an under-represented volume flow measurement value, use the factory default display configuration of l/min (liters per minute). Review of previous examination results ONLY if a clinical assessment reviewed a volume flow measurement(s) with the unit of measurement configured to display a value in milliliters. Firm's Customer Service Engineer will contact you to schedule a facility visit to update the system or inform you of a remote update when the software up |
| Quantity | 1990 |
| Distribution | US: MS, WA, TX, NJ, GA, PN, NY, AL, MN, NE, IN, CT, CA, IL, TN, WI, ND, NM, AR, NC, PR, RI, WY, MD, FL, HI, AZ, SC, MO, OK, VA, ME, KS, MI, LA, IA, OH, SD, NH, KY, AL, OR, MA, GU. OUS: Afghanistan, Albania, Algeria, Andorra, Angola, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangl |
| 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 |