Company: Welch Allyn Protocol, IncDate of Enforcement Report 8/5/2009 Class:ll PRODUCT Welch Allyn AED 10 automatic external defibrillator and MRL Jumpstart (collectively “AED 10”), Recall # Z-1656-2009 REASON Possible for users to misunderstand signals. The original product labeling told users that a flashing low battery indicator signals that the battery is low and requires changing...Read More

Company: Philips HealthcareDate of Enforcement Report 8/5/2009 Class:ll PRODUCT Philips IntelliVue Clinical Information Portfolio Software Version D.0, for patient data collection, storage, and management, Recall # Z-1654-2009 REASON Error in therapy scheduling: If scheduled orders are documented and edited prior to the orders’ original schedule time, ICIP can create a second instance of the same...Read More

Company: Hitachi Medical Corporation.Date of Enforcement Report 8/5/2009 Class:ll PRODUCT 1) Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less, Recall # Z-1651-2009; 2) Hitachi ECLOS Computed Tomography (CT) Scanners, Software Version 2.11 or less, Recall # Z-1652-2009 REASON Incorrect scale on image: A software error can occur if two (2) different Field-of-View...Read More