Day

February 9, 2011
Company: Vital Images Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Vital, Vitrea fX and Vitrea Enterprise Suite fX Model number: Vitrea fX 2.1, fX 3.0, and fX 3.1 Vitrea Enterprise Suite (VES) fX 1.2 and VES fX 1.3 The Vitrea 4D CT Brain Perfusion option is intended for post processing based on dynamic CT...
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Company:Images, Inc., Date of Enforcement Report 2/9/2011 Class ll: PRODUCT Vital Connect 4.0 & 4.1, radiological image processing software A Medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital images acquired from a variety of imaging devices including: CT MR, CR/DR/DX, SC, US, NM, PET, XA and RF, etc. Vital connect...
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Company: Varian Medical SystemsDate of Enforcement Report 2/2/2011 Class ll: PRODUCT 4D Integrated Treatment Console (4DITC); All versions up to and including 8.8.17 Designed to assist the operator of a radiation device in providing accurate treatment set-ups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while...
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Company: Varian Medical Systems.Date of Enforcement Report 1/26/2011 Class ll: PRODUCT Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System. Recall Z-0911-2011 REASON Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user...
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Company: Teco Diagnostics.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT 1) Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses...
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Company: Impac Medical Systems Inc., .Date of Enforcement Report 2/9/2011 Class ll: PRODUCT SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control. Recall # Z-1029-2011. REASON Computer interface is defected. Computer based verification system...
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Company: Impac Medical Systems Inc., .Date of Enforcement Report 2/9/2011 Class ll: PRODUCT SEQUENCER component of MOSAIQ versions 1.30 (all builds), 1.40 (all builds), 1.50 (all builds), 1.60 (all builds), and 2.0 (all builds). The intended use of SEQUENCER (a verification system) is to assist in the process of patient treatment on a radiotherapy treatment...
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Company: Philips Healthcare Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Physiological Monitoring, Patient Monitor M31250 Information Center Local Database Releases A, B, E.01, G, H, J, K, L, & M of Philips IntelliVue Information Center Software used in conjunction with PAS-210 Kit Remote Active Speakers. The intended use of the Information Center Software is...
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Company: Philips Healthcare Inc.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT Philips IntelliVue Clinical Information Portfolio (ICIP), Clinical Management System Software Version D.00 through D.03. Recall # Z-0414-2011. REASON Software: Scheduling function of the Philips Intellivue Clinical Information Portfolio Releases D.00 through D.03. Edits to a scheduled even frequency order may result in pending interventions...
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Company: Abbott Point of Care Inc.Date of Enforcement Report 2/9/2011 Class ll: PRODUCT i-STAT Level 2 Control Value Assignment Sheets Human Consumption. a) Abbott List Number: 06F13-01; b) Abbott List Number: 025715. Recall # Z-1020-2011. REASON Three i-STAT Level 2 Control Value Assignment Sheets and the i-STAT CLEW A20 Software System Manual Update CD contain...
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Company: GE Healthcare, LLC.Date of Enforcement Report 2/2/2011 Class ll: PRODUCT GE Healthcare Transport Pro Monitor with the CARESCAPE” Patient Data Module. Recall # Z-0363-2011. REASON Transport Pro Monitor stops communication with the CARESCAPE Patient Data Module (PDM) after 414 days of continuous run time. This time will equate to different amounts of real time...
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Company: Accuray Inc.Date of Enforcement Report 2/9/2011 Class ll: PRODUCT CyberKnife Treatment Planning System, a subsystem of the CyberKnife Robotic Radiosurgery System, with MultiPlan Treatment Planning System Software version 3.5 Medical charged-particle radiation therapy system, intended for treatment planning and image-guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body...
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Company: Accuray Inc..Date of Enforcement Report 2/9/2011 Class ll: PRODUCT Radiation therapy device. Medical charged particle radiation therapy system with software version. Model Numbers: Multi Plan Treatment Planning System, Software version 3.0, 3.1, 3.5.0, and 3.5.1. For the treatment planning and image guided radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the...
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Company: Radiometer America Inc. Date of Enforcement Report 2/9/2011 Class ll: PRODUCT ABL90 FLEX Blood Analyzer Part Number: 393-090. Intended for use by trained technologists, nurses, physicians and therapists and for use in a laboratory environment, near patient or point-of-care setting. Also, Intended for in vitro testing of samples of heparinized whole blood. Recall #...
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