FDA Device recall Z-2384-2016

Ingenuity Core128 Model No. 728323

FDA Device
Class II
terminated
Published 2016-08-17

On 2016-08-17 the FDA classified a Class II recall of Ingenuity Core128 Model No. 728323 by Philips Medical Systems Cleveland, citing software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2384-2016
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

Ingenuity Core128 Model No. 728323; To produce cross-sectional images of the body.

Reason

Software issues in v4.1.3/4.1.4/4.1.5 in the Philips Ingenuity CT products that could affect the performance of the equipment.

Identifiers

code_info	Ingenuity Core128 Model No. 728323 S/N:30023 30151 32000 32001 32008 32061 32065 32067 32076 32162 52023 52028 52049… Ingenuity Core128 Model No. 728323 S/N:30023 30151 32000 32001 32008 32061 32065 32067 32076 32162 52023 52028 52049 336177 30016 32012 32042 32044 32057 32068 32069 32100 32106 32138 32139 32140 32141 32142 32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153 32154 32155 32156 32157 32158 32159 32160 32161 32163 32164 32165 32166 32167 320001 320003 320006 320008 320010 320024 320026 320029 320031 320037 320054 320078 320090 320092 320107 320202 320224 320225 320226 320227 320228 320229 320230 320231 320232 320233 320234 320235 320236 320238 320239 320240 320241 320242 320243 320245 320246 320247 320248 320250 320251 320252 320254 320255 320256 320258 336011 336012 336015 336016 336018 336025 336027 336028 336029 336034 336040 336044 336068 336072 336076 336092 336100 336102 336104 336142 336148 336149 336150 336151 336152 336153 336154 336155 336156 336157 336158 336159 336160 336161 336162 336163 336164 336166 336167 336168 336170 336171 336172 336173 33617

code_info

Ingenuity Core128 Model No. 728323 S/N:30023 30151 32000 32001 32008 32061 32065 32067 32076 32162 52023 52028 52049…

Ingenuity Core128 Model No. 728323 S/N:30023 30151 32000 32001 32008 32061 32065 32067 32076 32162 52023 52028 52049 336177 30016 32012 32042 32044 32057 32068 32069 32100 32106 32138 32139 32140 32141 32142 32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153 32154 32155 32156 32157 32158 32159 32160 32161 32163 32164 32165 32166 32167 320001 320003 320006 320008 320010 320024 320026 320029 320031 320037 320054 320078 320090 320092 320107 320202 320224 320225 320226 320227 320228 320229 320230 320231 320232 320233 320234 320235 320236 320238 320239 320240 320241 320242 320243 320245 320246 320247 320248 320250 320251 320252 320254 320255 320256 320258 336011 336012 336015 336016 336018 336025 336027 336028 336029 336034 336040 336044 336068 336072 336076 336092 336100 336102 336104 336142 336148 336149 336150 336151 336152 336153 336154 336155 336156 336157 336158 336159 336160 336161 336162 336163 336164 336166 336167 336168 336170 336171 336172 336173 33617

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-2384-2016%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.