Company: AGFA Corp. Date of Enforcement Report 10/27//2010 Class ll: PRODUCT IMPAX CV Results Manager/Results Manager Administration Tool. Model No. L9M2100. Recall # Z-2112-2010 REASON Agfa Service technician had incorrectly modified a report template at one site resulting in erroneous anatomic segment locators. RECALLING FIRM/MANUFACTURER Recalling Firm: AGFA Corp., Greenville, SC, by letter on June...Read More

Company: GE HealthcareDate of Enforcement Report 10/27//2010 Class ll: PRODUCT GE Healthcare, CARESCAPE” Monitor B850, Software version 1.0.1.13 and 1.0.2.1 The CARESCAPE ” Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and...Read More