FDA (Devices) recall action 93874
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Canon Medical's MRI systems display incorrect Spatial Field Gradient values that are lower than actual, which may cause discomfort for patients with MR-conditional implanted devices during scanning.
Canon Medical's Vantage Elan MRI system may display incorrect maximum Spatial Field Gradient values, potentially causing discomfort in patients with MR conditional devices.
Vantage Titan MRI systems display and document spatial field gradient values that are lower than correct, which may cause discomfort in patients with MR-conditional devices.