Recall Z-2582-2023 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON Redwood 2.0 ultrasound systems, REF: 11503314
| Date | Sep 13, 2023 (initiated Jul 13, 2023) |
| Status | Open, Classified |
| Reason | If a user-generated preset for an 18L6 transducer created on a 1.0 ultrasound system is used with a 2.0 ultrasound system, the 2.0 ultrasound system will display underestimated measurement results when using an 18L6 transducer and viewing in the Dual format visualization function, which may lead to misdiagnosis of a patient's condition or influence patient management decisions in a negative way. |
| Root cause | Software design |
| Action | On 7/13/23, correction notices were emailed, mailed, or delivered to customers who were asked to do the following: What if I imported my user-generated presets of an 18L6 transducer from an ACUSON Redwood 1.0 system onto an ACUSON Redwood 2.0 system, then used an 18L6 transducer with Dual format to perform patient examinations using my ACUSON Redwood 2.0 system? Review any ultrasound examination results obtained in this situation. Only measurements taken from an 18L6 transducer within Dual format on ACUSON Redwood 2.0 systems are impacted. Ensure that all users of affected ultrasound systems |
| Quantity | 796 |
| Distribution | Worldwide - US Nationwide distribution including in the states of IL, WI, CA, NM, TX, NC, MI, MD, NY, OH, IN, NE, PA, LA, SC, MO, OK, VA, ME, AZ, PR, IA, NH, NJ, AR, FL, SD and the countries of GR, ES, SG, TH, KR, IN, DE, TR, AT, IT, AU, JP, FR, CA, PT, SK, BR, SA, GB, NZ, RO, SE, AE, CN, HR, PL, CH |
| 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 |