FDA (Devices) recall action 76373
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.
Image data transferred from the MRI system to a workstation showed errors on the slice position reference image.
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.
Hitachi Medical Systems America Inc is recalling 210 Hitachi Oasis MRI Systems because image data transferred to workstations showed errors on the slice position reference image.
Hitachi Medical Systems America Inc is recalling 68 Hitachi Echelon MRI Systems because image data transferred to workstations showed errors on the slice position reference image.
Hitachi Medical Systems America Inc is recalling 25 Hitachi Echelon Oval MRI Systems because image data transferred to workstations showed errors on the slice position reference image.