FDA Device recall Z-0518-2018
Philips Brilliance 64 computed tomography x-ray system
- FDA Device
- Class II
- terminated
- Published 2018-02-14
On 2018-02-14 the FDA classified a Class II recall of Philips Brilliance 64 computed tomography x-ray system by Philips Medical Systems Cleveland, citing numerous issues related to software Brilliance iCT 4.1.6 software version.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0518-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-10-06 |
| Published | 2018-02-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
Philips Brilliance 64 computed tomography x-ray system
Reason
Numerous issues related to software Brilliance iCT 4.1.6 software version.
Identifiers
| code_info | Brilliance 64 Code 728231 SN#: 4001 4016 9056 9067 9071 9074 9099 9112 9134 9194 9213 9235 9251 9263 9…Brilliance 64 Code 728231 SN#: 4001 4016 9056 9067 9071 9074 9099 9112 9134 9194 9213 9235 9251 9263 9268 9269 9272 9280 9367 9515 9515 9521 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9579 9584 9600 9607 9614 9618 9625 9631 9633 9638 9640 9646 9649 9653 9656 9659 9667 9670 9678 9686 9688 9689 9703 9707 9711 9720 9738 9740 9755 9761 9763 9781 9782 9788 9802 9805 9808 9811 9822 9833 9837 9838 9859 9862 9864 9867 9876 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9950 9969 9983 9989 9993 9996 9997 10012 10014 10021 10024 10032 10042 10046 10047 10050 10051 10060 10069 10072 10076 10077 10092 10099 10102 10106 10121 10137 10150 10151 10173 10179 10180 10193 10200 10203 10206 10206 10207 10208 10213 10216 10221 10247 10250 10255 10288 10299 10302 10307 10310 10316 10351 10379 10391 10394 10418 10422 10446 10470 10473 |
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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-0518-2018%22
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