FDA Device

Sedecal NOVA FA DR System. for diagnostic radiography.

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.

What You Should Do

Remedy

Initial communication from SEDECAL to all our distributors was performed on 07/18/2018 by email. The letter explained the problem and requested the consignee cease use of the unit if they observe an abnormal displacement in the vertical axis or any suspicious noise during the vertical movement.

Products

Sedecal NOVA FA DR System. for diagnostic radiography.
Brand
Sedecal S.A. Pol. Industrial Rio De Janiero Calle Pelaya 9-13 Algete Spain
UPC
Serial Numbers 07360816 through 17291024

Units Affected

145 units