FDA-Device2018-01-10Class II
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
Philips Electronics North America Corporation
Hazard
If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.
Sold states
412 units affected.
Affected count
412
Manufactured in
3000 Minuteman Rd, N/A, Andover, MA, United States
Products
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0311-2018Don't want to check this manually?
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