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April 9, 2014
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...
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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...
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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....
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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....
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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...
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/docs/FDApremarketReviewCommunicationsGuidance040414.pdf
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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...
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