ACUSON SC2000 Ultrasound Systems between software versions VA16A and VA30A and with the Stress Echo Option. Model number 10433816: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications. The system also provides the ability to measure anatomical structures and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

When performing a 2D Stress Echo study, some following keystrokes result in a potential loss of data, where some selected clips may not be saved as part of the study.

Siemens sent an Customer Safety Advisory Notification on May 29,2015, to all affected customers. The letter identified the product the problems and the action needed to be taken by the customer. Customer Safety Advisory notifications inform users of the potential issue with the ACUSON SC2000 systems with software versions between VA16! and VA30A and the Stress Echo feature. Letters describe the steps that result in the potential loss of data and suggest that the following steps be taken to remedy the situation: 1. Select Stress Echo Selection 2. If applicable relabel the clips for all Stages and Views 3. Do not return to Stress Echo Selection to select additional relabeled clips. The issue will be resolved in an upcoming software release for customers who did not receive the original software update. Until the necessary repairs have been completed, all personnel in the Organization who need to be aware of the issue should be notified. For further questions please call (650) 694-5398.