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Swissray Medical recalls ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Recalled September 26, 2018 · FDA recall Z-3191-2018 · Swissray Medical
Hazard
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly. · FDA Class II
Units
27 devices in US
Sold at
Worldwide Distribution: US (Nationwide) and to countries of: Austria, Dubai, China. Germany, Libya, Malaysia, Russia, and South Africa.
Description
Potential for bucky (the part that holds the grid and is moveable to position the patient) moving unexpectedly.
Product
ddR Formula B X-ray System, Model ddR Formula B X-ray system used for imaging
Manufacturer(s)
Swissray Medical
Made in
Switzerland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →