Recall Z-0488-2019 ยท MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Sedecal S.A.
Sedecal NOVA FA DR System. for diagnostic radiography.
| Date | Jul 18, 2018 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 145 units |
| Distribution | US and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133782 | NOVA FA DR SYSTEM Sedecal., Sa., Mar 21, 2014 |