Company: Micro Typing Systems, Inc.Date of Enforcement Report 8/10/11 Class ll: PRODUCT ORTHO Pro Vue, Software Version 3.1. Upon turning the ORTHO Pro Vue on, the screen that appears immediately after the log in screen is the one that contains the Software Version. Software version is located in the upper right hand corner of the...Read More

Company: AGFA Corp.Date of Enforcement Report 8/10/11 Class ll: PRODUCT IMPAX CV (Cardio Vascular) The IMPAX Cardiovascular suite is a cardiovascular information system, providing archiving, image display and modality/study specific structured reporting. Recall # Z-2552-2011 REASON Customer error with the angiography (XA: X-Ray Angiography) measurement calibration functionality within the Cardiovascular Review Station resulted in improper...Read More

Company: Hitachi Medical Systems America Inc.Date of Enforcement Report 8/10/11 Class ll: PRODUCT Hitachi HIVISION Preirus/Avius Ultrasound equipped with V03.02 Software – Doppler Trace Measurement program. 510 (k) Numbers: Preirus – K093466 (6/1/10), Avius – K102901 (10/27/10). The Preirus and Avius are intended for use by trained personnel (doctors, sonographers, etc) for the diagnostic ultrasound...Read More