FDA-Device2018-11-28Class II
Sedecal NOVA FA DR System. for diagnostic radiography.
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.
Sold states
US and Canada
Affected count
145 units
Manufactured in
Pol. Industrial Rio De Janiero, Calle Pelaya 9-13, Algete, N/A, Spain
Products
Sedecal NOVA FA DR System. for diagnostic radiography.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0488-2019Don't want to check this manually?
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