Company:Sendx Medical IncDate of Enforcement Report 2/17/2010 Class:ll PRODUCT ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The...Read More

Company:Stryker ImagingDate of Enforcement Report 2/17/2010 Class:ll PRODUCT Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010 REASON Firm has determined Guardian Services does not contain 100% data backup for...Read More