Sedecal NOVA FA DR System. for diagnostic radiography.
- Recall Initiated
- July 18, 2018
- Recall Number
- Z-0488-2019
- Quantity
- 145 units
Reason for Recall
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.
Distribution
US and Canada
Lot / Code Info
Serial Numbers 07360816 through 17291024
Root Cause
Device Design
Action Taken
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.