FDA Device recall Z-2381-2016

Brilliance iCT, Model No. 728306

FDA Device
Class II
terminated
Published 2016-08-17

On 2016-08-17 the FDA classified a Class II recall of Brilliance iCT, Model No. 728306 by Philips Medical Systems Cleveland, citing software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2381-2016
Classification	Class II
Status	terminated
Initiated	2016-04-29
Published	2016-08-17
Last updated	2026-09-13 11:54 UTC
Company	Philips Medical Systems Cleveland
Distribution	AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV, WY

Product

Brilliance iCT, Model No. 728306; To produce cross-sectional images of the body.

Reason

Software issues in versions v4.1 .3/4.1.5 in the Philips Brilliance iCT) iCT SP products that, could affect the performance of the equipment.

Identifiers

code_info	Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725… Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725 100726 100727 100728 100105 100123 100130 100132 100141 100146 100159 100328 100375 100378 100473 100700 100703 100709 100710 100711 100712 100713 100717 100720 100162 85003 85004 85010 85012 85013 85014 85015 85016 85017 85018 85019 85020 85021 85022 85023 85024 85025 85026 85027 85028 85029 85030 85031 85032 85033 85034 85035 85036 85037 85038 85039 85040 85041 85042 85043 85044 85045 85046 85047 85048 85049 85050 85051 85052 85053 85054 85055 85056 85057 85058 85059 85060 85061 85062 85063 85064 85065 85066 85067 85068 85069 85070 100016 100018 100019 100022 100024 100025 100037 100038 100040 100044 100048 100049 100050 100051 100053 100054 100058 100062 100064 100065 100070 100072 100082 100084 100091 100093 100094 100099 100101 100103 100111 100113 100114 100115 100119 100122 100125 100131 100133 100134 100135 100140 100144 100149 100153 100161 100165

code_info

Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725…

Brilliance iCT Model No. 728306 S/N:85071 85072 100150 100349 100695 100715 100716 100719 100721 100723 100724 100725 100726 100727 100728 100105 100123 100130 100132 100141 100146 100159 100328 100375 100378 100473 100700 100703 100709 100710 100711 100712 100713 100717 100720 100162 85003 85004 85010 85012 85013 85014 85015 85016 85017 85018 85019 85020 85021 85022 85023 85024 85025 85026 85027 85028 85029 85030 85031 85032 85033 85034 85035 85036 85037 85038 85039 85040 85041 85042 85043 85044 85045 85046 85047 85048 85049 85050 85051 85052 85053 85054 85055 85056 85057 85058 85059 85060 85061 85062 85063 85064 85065 85066 85067 85068 85069 85070 100016 100018 100019 100022 100024 100025 100037 100038 100040 100044 100048 100049 100050 100051 100053 100054 100058 100062 100064 100065 100070 100072 100082 100084 100091 100093 100094 100099 100101 100103 100111 100113 100114 100115 100119 100122 100125 100131 100133 100134 100135 100140 100144 100149 100153 100161 100165

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-2381-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.