FDA (Devices) recall action 70478
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
It was discovered that the upper left corner-shaped lead shield in the window in one of the doors of the v|tome|x L240 installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
It was discovered that the upper left corner-shaped lead shield in the window in one of the doors installed had lost adhesion and fall out of position, which could lead to gaps in shielding.
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.
GE Inspection Technologies is recalling two x|tome|x L240 X-ray systems because a lead shield fell out of position, creating potential radiation exposure gaps.
GE Inspection Technologies is recalling two x|argos 160D cabinet x-ray systems because a lead shield fell out of position, creating potential radiation gaps.