FDA Device recall Z-1408-2018
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cro…
- FDA Device
- Class II
- terminated
- Published 2018-04-25
On 2018-04-25 the FDA classified a Class II recall of Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cro… by Philips Medical Systems Cleveland, citing closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1408-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-08 |
| Published | 2018-04-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.
Reason
Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Identifiers
| code_info | Serial No: 100410 100608 100611 100413 85071 100816 100667 85031 100654 100667 100604 100703 85031 85054…Serial No: 100410 100608 100611 100413 85071 100816 100667 85031 100654 100667 100604 100703 85031 85054 100672 100638 100616 100619 85078 100669 85048 85060 85062 100666 85058 85082 100304 85067 85063 100704 100769 100722 100600 100628 100771 100621 100627 100738 100615 100602 100617 100635 100624 100636 100696 100639 100651 100643 100642 100659 100640 100644 100669 100734 100662 100706 100716 100691 100711 100727 100683 100760 100677 100709 100692 100717 100678 100697 100687 100733 100732 100799 100736 100740 100778 100749 100809 100751 100762 100755 100746 100766 100763 100757 100765 100773 100783 100772 100775 100797 100780 100784 100787 100798 100786 100768 100612 100614 100622 100637 100656 100710 100666 100735 100680 100713 100707 100701 100698 100712 100785 100726 100776 100792 100745 100737 100767 100758 100781 100750 100814 100807 85015 85016 85026 8502 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2018%22
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