Company: Brainlab AG Date of Enforcement Report 11/25/2015 Class lI: PRODUCT BrainLAB Image Guided Surgery (IGS) System, Stereotaxic Instrument navigation software, Cranial ENT version 2.1, and Spine and Trauma 3D versions 2.0 and 2.1 An intraoperative image-guided localization system to enable minimally invasive surgery. Recall Number Z-0282-2016 REASON nstances of data sets not being accurately...Read More

Company: AGFA Healthcare Corp.Date of Enforcement Report 11/25/2015 Class lI: PRODUCT IMPAX, PACS, Picture Archive and Communications System, IMPAX CV 7.8.x and IMPAX CV 12.x. Corrects certain demographic information (Patient Name, Patient Medical Record Number and/or Accession Number in previously signed reports that have since changed. Recall Number Z-0283-2016 REASON Customers have experienced IMPAX CV...Read More