Recall Z-2314-2015 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017 S 2000 system 10441730 S 3000 system 10441701 S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/
| Date | Jul 29, 2015 (initiated Jun 25, 2015) |
| Status | Terminated |
| Reason | Potential measurement error on ACUSON S Family ultrasound system when using the Doppler manual trace measurement tool in full screen format that has a low probability of misdiagnosis. |
| Root cause | Device Design |
| Action | Customer Safety Advisory notifications were sent by certified mail to US customers on June 25, 2015. Siemens Service organization coordinate the implementation of the field correction with the distributors for all countries. Letters advised users of the potential miscalculation on ACUSON S1000, ACUSON S2000, or ACUSON S3000 ultrasound systems with software version VC30A, VC30B, VC30C, or VC31A. The manual trace tool may incorrectly calculate the Time Average Velocity and subsequently incorrectly calculate the Pulsatility index. This could lead to potential misdiagnosis. To mitigate the probl |
| Quantity | 1789 units |
| Distribution | Worldwide Distribution - Nationwide Distribution including Puerto Rico and to the countries of : Algeria, Angola, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia Herzeg., Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Dem. Rep. Cong |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132804 | ACUSON S1000 / S2000 / S3000 Siemens Medical Solutions USA, Inc. Ultrasound Gro, Oct 24, 2013 |