Recall Z-1821-2017 ยท OWB Interventional Fluoroscopic X-Ray System
Philips Electronics North America Corporation
UNIQ: UNIQ FD10 722026; UNIQ FD10/10 722027; UNIQ FD20/10 biplane 722029; UNIQ FD10 OR Table 722033; UNIQ FD10/10 OR Table 722034; UNIQ FD20/10 OR Table 722036; UNIQ FD20/20 722038; UNIQ FD20/20 biplane OR Table 722039
| Date | Mar 22, 2017 |
| Status | Terminated |
| Reason | Due to a leak in the detector cooling system, cooling liquid may leak outside the drip tray of the chiller. If this occurs the liquid may drip onto electrical components in the R cabinet located in the technical room, which could lead to damage to the system and potentially cause thermal events such as a burning odor, smoke or fire. |
| Root cause | Under Investigation by firm |
| Action | Consignees were notified of the recall via letter sent on 3/22/2017. The letter explains the issue, actions that should be taken by the customer, and actions to be taken by Philips. |
| Quantity | 6992 (total for all devices) |
| Distribution | Nationwide, worldwide including Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.