Company:Siemens Medical Solutions USA, Inc.
Date of Enforcement Report: 5/13/2015
Class lI:
PRODUCT
ACUSON SC2000 volume imaging ultrasound systems at software versions VA16C, VA16D and VA16E. Model 10433816. Product Usage: 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. Typical examination performed using the SC2000 Ultrasound System are: Cardiac Imaging Applications and Analysis; Vascular Imaging Applications and Analysis; Superficial Imaging Applications; Intraoperative Imaging Applications; Transcranial Imaging Applications;
Recall Number Z-1581-2015
REASON
In some cases, the system is unable to capture a clip or image during a routine scan.
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc, Mountain View, CA on 5/11/2012 Voluntary: Firm Initiated recall has been termindated
VOLUME OF PRODUCT IN COMMERCE
186 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
