Company:SCC Soft ComputerDate of Enforcement Report: 2/18/2015 Class lI: PRODUCT SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10, 4.3.0.11, 4.3.0.12, 4.3.0.14, 4.3.0.15, and 4.4.0.0 Recall Number Z-1065-2015 REASON Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report,...Read More

Company: Natus Medical Incorporated Date of Enforcement Report 2/18/2015 Class lI: PRODUCT EPWorks software used in the Xltek Protektor Stimulator Product Usage: Intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, laceration, or compression) or vascular insufficiency. Recall Number Z-1068-2015 REASON Software error occurs when using remote monitoring;...Read More

Company: Natus Medical Incorporated Date of Enforcement Report 2/18/2015 Class lI: PRODUCT Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to...Read More

Company:TeraRecon, Inc.Date of Enforcement Report: 2/18/2015 Class lI: PRODUCT Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture Archiving and Communications System; Findings Workflow Modules 4.4.11.82.6784, 4.4.11.116.7134, 4.4.11.144.7589. A fully-configured iNtuition system is capable of various image processing and visualization functions, including basic features and advanced post processing modules. The system can be configured...Read More