Company: Siemens Medical Solutions USA, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Siemens syngo.plaza image processing system image processing radiological system Recall Number Z-0271-2014 REASON The firm became aware of an unintended behavior when using the syngo.plaza. The “Rename” functionality can cause an unintended patient merge if the patient is sent to another...Read More
Company: RAYSEARCH LABORATORIES AB. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0 Recall Number Z-0281-2014 REASON Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a...Read More
Company:Philips Healthcare Informatics, Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a software package used with general purpose computing hardware to acquire, store, distribute, process and display images and associated data throughout a clinical environment. Product is manufactured and distributed by Philips Healthcare...Read More
Company:Nobel Biocare Usa Llc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001. Device Name: Osseocare Pro console & Set Osseocare Pro. Model: 1600870-001, 1700470-001, 1700471-001. Marketing status: Class I, under K092214. Device description: Software-based, electronically controlled tabletop device. In dentistry for dental surgery,...Read More
Company: Hospira Inc Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT ) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PLUM A+3; for use with Hospira MedNet; *** 2) Plum A+ Infusion Pump; List Number: 20679; Labeled in part: PLUM A+; for use with Hospira MedNet; *** 3) Plum A+ Infusion Pump with...Read More
Company: GE Healthcare, LLC Date of Enforcement Report:11/20/2013 Class ll: PRODUCT AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.): AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION): AW Server. K052995: Advantage Workstation 4.3 is a review station, which allows easy selection, review, processing and filming of multi-modality DICOM images from a variety of diagnostic imaging systems....Read More
Company: Carestream Health Inc. Date of Enforcement Report: 11/20/2013 Class lI: PRODUCT Carestream Vue PACS; VIRTUAL ACCESS SOFTWARE, WORKGROUP The CARESTREAM PACS is an image management system whose intended use is to provide completely scaleable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve and display images and...Read More
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John is currently providing telephone and face-to-face meetings to discuss: Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.
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