Recall Z-1774-2021 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
| Date | Apr 13, 2021 |
| Status | Terminated |
| Reason | Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury |
| Root cause | Under Investigation by firm |
| Action | Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service. |
| Quantity | 2 units (1 US and 1 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060937 | BRILLIANCE VOLUME Philips Medical Systems (Cleveland), Inc., Jun 5, 2006 |