Company: Mckesson Information Solutions LLC.Date of Enforcement Report:10/15/2014 Class lI: PRODUCT McKesson Cardiology” Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. Recall Number Z-0042-2015 REASON Software Error: The McKesson Cardiology Hemo calculation section incorrectly converts the Hemoglobin value before it is utilized in the applicable formula...Read More

Company: GE Healthcare Date of Enforcement Report: 10/15/2014 Class lI: PRODUCT GE Healthcare Carescape Patient Data Module Recall Number Z-0060-2015 REASON GE Healthcare has recently become aware of a potential safety issue to the ECG calculations following a disconnect/reconnect cycle with the Patient Data Module, when used with the Carescape Bx50 monitors. If the PDM...Read More