Company: Philips Healthcare Inc. Date of Enforcement Report 11/9/11 Class ll: PRODUCT MDC PACS – release R2.3 SP1. A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD). Recall # Z-0032-2012 REASON Clinical measurements on true size...Read More

Company: Beckman Coulter Inc. Date of Enforcement Report 11/9/11 Class ll: PRODUCT 1) SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as...Read More