Company ZOLL Medical Corporation.Date of Enforcement Report:4/9/2014 Class lI: PRODUCT Zoll Medical X Series, PropaqMD, PropaqM Defibrillator/Pacemaker/Monitor With System Software Version 02.10.02.00 or Higher, automated external defibrillator. Recall Number Z-1311-2014 REASON Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used RECALLING FIRM/MANUFACTURER ZOLL Medical Corporation, Chelmsford, MA on.3/52014. Voluntary: Firm Initiated...Read More
Company Spacelabs Healthcare, Llc.Date of Enforcement Report:4/9/2014 Class lII: PRODUCT TDWorkstation version 11.01.A or higher. TDWorkstation receives patient results from a connected instrument and sends them to a Laboratory Information System (LIS). Recall Number Z-1310-2014 REASON If a conflict occurs between a Demography Query and a Result Transmission by the instrument, the TDWorkstation could send...Read More
Company RAYSEARCH LABORATORIES AB.Date of Enforcement Report:4/9/2014 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System, models 2.5, 3.0, 3.5 and 4.0; a software system designed for treatment planning and analysis of radiation therapy. Recall Number Z-1307-2014 REASON Potential for dose errors due to software program errors.. RECALLING FIRM/MANUFACTURER RAYSEARCH LABORATORIES AB, Stockholm, Sweden on.2/6/2014....Read More
Company RAYSEARCH LABORATORIES AB.Date of Enforcement Report:4/9/2014 Class lI: PRODUCT RaySearch Ray Station, Radiation Therapy Treatment Planning System, Stand-alone software.Recall Number Z-1308-2014 REASON RaySearch Laboratories has recalled RaySearch Ray Station 4.0 software due to clinical dose calculation errors during radiation therapy. RECALLING FIRM/MANUFACTURER RAYSEARCH LABORATORIES AB, Stockholm, Sweden on.2/6/2014. Voluntary: Firm Initiated recall is ongoing....Read More
Company: Philips Medical Systems, Inc. Date of Enforcement Report 4/9/2014 Class lI: PRODUCT Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0. Recall Number Z-1312-2014 REASON Philips Medical Systems have recently determined that a software nonconformance can cause incorrect beam geometry. This issue affects Pinnacle3 Radiation Therapy Planning (RTP) System, software version 9.0 manufactured from...Read More
Company:Elekta, Inc.Date of Enforcement Report:4/92/2014 Class lI: PRODUCT Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. Recall Number Z-1322-2014 REASON The problem is that the “static tolerances” from...Read More
FDA and 62304 Training – Boston – June 4-6, 2019
3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well. John F. Murray, Jr., will be among the faculty!