Company:St Jude Medical.Date of Enforcement Report: 3/25/2015 Class lI: PRODUCT TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz catheter tip and the heart wall. Product Usage: This device is indicated for use in cardiac electrophysiological mapping and for...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 3/25/2015 Class lI: PRODUCT Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories Recall Number Z-1282-2015 REASON There is a potential safety risk when using LANTIS server software with operating systems with which it...Read More

Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 3/25/2015 Class lI: PRODUCT ARTISTE MV System, Linear Accelerator (LINAC) with SysVC10A software. The intended use of the ARTISTE MV System linear accelerator system is to deliver x-ray radiation for therapeutic treatment of cancer. Recall Number Z-0984-2015 REASON There may be an existing dark current phenomenon on...Read More

Company:Mindray DS USA, Inc. dba Mindray North AmericaDate of Enforcement Report: 3/25/2015 Class lI: PRODUCT VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following Passport V Monitor, Multiparameter Patient Monitor(with Arrhythmia Detection and Alarms) Intended for intra hospital use under the direct supervision of a licensed healthcare practitioner. Recall Number Z-1280-2015 REASON...Read More