Device product
Sedecal NOVA FA DR System. for diagnostic radiography.
Z-0488-2019
Product summary
- Firm
- Sedecal S.A.
- Event
- Event 81377
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 145 units
- Official record key
device-enforcement:Z-0488-2019
Official wording
Reason: 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.
Code information: Serial Numbers 07360816 through 17291024
Distribution pattern: US and Canada
Derived failure modes
-
Unknown
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.