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Sedecal S.A. recalls Sedecal NOVA FA DR System. for diagnostic radiography.
Recalled November 28, 2018 · FDA recall Z-0488-2019 · Sedecal S.A
Hazard
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties. · FDA Class II
Units
145 units
Sold at
US and Canada
Description
A safety problem with installation and maintenance could lead to the breakage of the two steel cables that support the equipment to its roof anchor. Due to this, the equipment may fall and cause harm to the patient, user, or third parties.
Product
Sedecal NOVA FA DR System. for diagnostic radiography.
Manufacturer(s)
Sedecal S.A.
Made in
Spain
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →