This content is only available to Premium and higher subscribers.  See our Subscribe page for information on subscriptions. SoftwareCPR checklist for "IEC 82304-1: Health software - Part 1: General requirements for product safety."  Download: IEC 82304 SoftwareCPR Checklist SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device...Read More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Ultimax DREX-ULT80, Model No. KXO-80XM Multipurpose digital x-ray system for gastrointestinal studies, vascular studies, general radiography, and fluoroscopy Recall Number Z-1022-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an examination....Read More

Company: Toshiba American Medical Systems Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Kalare DREX-KL80, Model No. KXO-80XD Diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations Recall Number Z-1021-2017 REASON It has been found that the generator of the system could possibly terminate the exposure prematurely during an...Read More

SoftwareCPR has posted its new checklist for “IEC 82304-1: Health software – Part 1: General requirements for product safety” in our website library and on our checklists page. This is free for our paid subscribers. SoftwareCPR can provide conformance assessments, training, or expert consultation for efficient use and implementation of 82304 for medical device software...Read More

Company: Siemens Medical Solutions USA, Inc Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Artis zee/zeego, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be...Read More

Company: Philips Medical Systems, Inc. Date of Enforcement Report 1/18/20176 Class lI: PRODUCT IQon Spectral CT with software version 4.7.0Product Usage:The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Recall Number Z-1006-2017 REASON...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer. Recall Number Z-0987-2017 REASON Cross profile for Varian 60 degree wedge shows “horns.”...Read More

Company: Elekta, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy. Recall Number Z-1009-2017 REASON Incorrect Enhanced Dynamic Wedge (EDW) or Virtual Wedge (VW) Calculations. RECALLING FIRM/MANUFACTURER Elekta inc., Atlanta, GA on 12/21/2016. Voluntary: Firm Initiated...Read More

Company:Varian Medical Systems, Inc. Date of Enforcement Report 1/18/2017 Class lI: PRODUCT Eclipse Treatment Planning System version 13.MR2 [13.06.31 with Smart Segmentation Knowledge Based Contouring version 2.3 [2.3.12] Radiology: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan...Read More