Informal Request for ATI Records Previously Released

Organization: Health Canada

Year: 2024

Month: November

Request Number: A-2022-001525

Request Summary: Records of medical device incident reports, recalls, safety assessments and surveillance reports for General Electric (GE) Lightspeed Computed Tomography (CT) scanner devices from the date of authorization to March 1, 2009. Submission documents and communications related to the design and retrofitting of the GE Lightspeed CT scanner console. The number of GE Lightspeed CT scanners sold in Canada from the date of authorization to March 1, 2009. Any records regarding the replacement, maintenance, or inspection of any GE Lightspeed CT scanner consoles at Abbotsford Regional Hospital. Any documented communication between Health Canada and The Food and Drug Administration of the US regarding issues around the GE Lightspeed CT scanner console and reports of injuries arising from said design. Any bulletins / advisories, communication released to health care end users / Provincial Governments by Health Canada regarding issues of design that may cause radiation overdoses as a result of a console design of the GE Lightspeed CT.

Disposition: Disclosed in part

Number of pages: 97

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