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...
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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...
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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...
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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...
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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.,...
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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...
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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...
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