Company:Siemens Medical Solutions USA, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body,...Read More
Company:RAYSEARCH LABORATORIES ABDate of Enforcement Report: 4/1/2015 Class lI: PRODUCT RayStation Radiation Therapy Treatment Planning System; — RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation...Read More
Company:Brainlab AGDate of Enforcement Report: 4/1/2015 Class lI: PRODUCT ExacTrac versions 6.x patient positioning systems are used to position patients during radiosurgery or radiotherapy procedures.. Recall Number Z-1316-2015 REASON The ExacTrac 6.x Patient Positioning System may incorrectly position the patient when using the ExacTrac Cone Beam CT (CBCT) with a TrueBeam-specific optional subvolume-CBCT.. RECALLING FIRM/MANUFACTURER...Read More
Company:CareFusion 303, Inc.Date of Enforcement Report: 4/1/2015 Class lI: PRODUCT Alaris PC units, Model No. 8015. Infusion pump. Recall Number Z-1311-2015 REASON CareFusion is recalling the Alaris PC unit because of an error code. The error code may occur upon power on during the “Power-On Self Test” due to a keypad issue. RECALLING FIRM/MANUFACTURER CareFusion...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email firstname.lastname@example.org for more info.