Day

March 12, 2014
Company:Toshiba American Medical Systems IncDate of Enforcement Report:3/12/2014 Class lI: PRODUCT TSX-101A Aquilion 32/64 ONE Computed Tomography X-Ray System; TXS-101/R Aquilion RXL Computed Tomography X-Ray System; TSX-301A Aquilion One Computed Tomography X-Ray System; TSX-301B Aquilion Premium Computed Tomography X-Ray System; TSX-302A Aquilion Prime Computed Tomography X-Ray System. This device is indicated to acquire and display...
Read More
Company: GE Healthcare LLC Date of Enforcement Report:3/12/2014 Class lI: PRODUCT GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-2 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-3 GSI Viewer 1.10 on AW VolumeShare 4 (AW 4.5); 5342114-4 GSI Viewer 1.11 on AW VolumeShare 4 (AW...
Read More
Company: GE Healthcare LLC Date of Enforcement Report:3/12/2014 Class lI: PRODUCT GE Healthcare Solar 8000M and Solar 8000i Patient Monitor software version 5.4, 5.5, or 5.6 with the Automatic-View-On- Alarm (AVOA) feature enabled. The Solar 8000i with Patient Data Module / Transport Pro with Patient Data Module is intended for use under the direct supervision...
Read More
Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT TSX-301C Aquilion One (Vision Edition) Computed Tomography X-Ray System. Recall Number Z-0972-2014 REASON Toshiba America Medical Systems, Inc. initiated this recall due to the failure of the parts used in the X-ray high-voltage generator. In some cases, X-ray exposure cannot be performed. RECALLING FIRM/MANUFACTURER Elekta Inc., Atlanta...
Read More
Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT Integrity. Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. Recall Number Z-1083-2014 REASON During the treatment table, gantry, and collimator calibration procedures, it is possible to type incorrect values or invert a value. RECALLING FIRM/MANUFACTURER Elekta Inc.,...
Read More
Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT RT Desktop The EOS RT Desktop, as with the predicate SL/SLi Series user interface, is intended to be used as the user interface for the SL/SLi Series Linear Accelerators that are used for the radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical...
Read More
Company:Elekta, Inc.Date of Enforcement Report:3/12/2014 Class lI: PRODUCT 1. Agility. Version 3.0 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Recall Number Z-1084-2014 2. Agility. Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital...
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 training@softwarecpr.com for more info.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.