Company:Philips Healthcare Inc. Date of Enforcement Report 12/21/11 Class ll: PRODUCT Philips Multi Diagnost Eleva with Flat Software R5.2.2. Philips MultiDiagnost Eleva system is intended to be Intended used as a multifunctional/Universal system. General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications. This includes the following general areas: Digestive...Read More

Company:AGFA Corp. Date of Enforcement Report 12/21/11 Class ll: PRODUCT IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR) The IMPAX Cardiovascular suite is a cardiovascular Information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0212-2012 REASON Incorrect entries in mapping files could lead to inaccurate measurement display...Read More

Company:AGFA Corp. Date of Enforcement Report 12/21/11 Class ll: PRODUCT IMPAX CardioVascular (CV) Admin Tool The IMPAX Cardiovascular suite is a cardiovascular information system providing image archiving and image display and modality study-specific structured reporting. Recall # Z-0272-2012 REASON Potential for misattribution of data and for a report to become unavailable when the user requests...Read More