Recall Z-2051-2011 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
ACUSON S2000 ultrasound system Manufactured by Siemens Medical Solutions USA, Inc. Business Unit Ultrasound, 1230 Shorebird Way Intended for the following applications: Fetal, abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular Applications.
| Date | Apr 22, 2011 (initiated Mar 15, 2011) |
| Status | Terminated |
| Reason | The Firm discovered a software error on the Accuson S2000 ultrasound systems affecting the measurement results in the patient report. |
| Root cause | Software design |
| Action | Siemens issued a Customer Safety Advisory Notification letter to all customers on March 15, 2011, regarding a software error on the ACUSON S2000 ultrasound systems affected measurement . They are in the process of releasing a software update that will correct this issue. Siemens recommends reviewing the patient report at the end of each study to confirm that the report contains only measurements relevant to the exam just performed. No patient injury has been reported. Further questions regarding this recall please call (650) 694-5398. |
| Quantity | 1533 units |
| Distribution | Worldwide Distribution including USA, states of AZ, VA, CA, NE, IL, MN, TN, FL, NM, and DC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082142 | ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Ultrasound DI, Nov 13, 2008 |