FDA Device recall Z-2383-2016

Ingenuity Core Model No. 728321

FDA Device
Class II
terminated
Published 2016-08-17

On 2016-08-17 the FDA classified a Class II recall of Ingenuity Core Model No. 728321 by Philips Medical Systems Cleveland, citing software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-2383-2016
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 Core Model No. 728321; To produce cross-sectional images of the body.

Reason

Software issues in software versions v4.1.3/4.1.4/4.1.5 in the Philips Brilliance 64 and Ingenuity CT products that could affect the performance of the equipment.

Identifiers

code_info	Ingenuity Core Model No. 728321 S/N:31001 52030 52031 52044 52050 310292 333064 52000 52012 52015 52018 52020 52022 5… Ingenuity Core Model No. 728321 S/N:31001 52030 52031 52044 52050 310292 333064 52000 52012 52015 52018 52020 52022 52063 310001 310022 310023 310026 310032 310039 310096 310105 310133 310135 310157 310160 310209 310210 310211 310212 310213 310214 310215 310216 310217 310218 310219 310220 310221 310222 310223 310224 310225 310226 310227 310228 310229 310230 310231 310232 310233 310234 310236 310237 310238 310239 310240 310241 310242 310243 310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256 310257 310258 310259 310260 310261 310262 310263 310264 310265 310266 310267 310269 310270 310271 310272 310273 310274 310275 310276 310277 310278 310279 310280 310281 310282 310283 310284 310285 310287 310288 310289 310290 310291 333002 333005 333010 333015 333018 333021 333042 333043 333051 333060 333061 333106 333107 333108 333109 333110 333112 333114 333115 333116 333117 333121 52035 333068 33084 52007 52008 52010 52013 52014 52019 52021 52024 52025 52026 52

code_info

Ingenuity Core Model No. 728321 S/N:31001 52030 52031 52044 52050 310292 333064 52000 52012 52015 52018 52020 52022 5…

Ingenuity Core Model No. 728321 S/N:31001 52030 52031 52044 52050 310292 333064 52000 52012 52015 52018 52020 52022 52063 310001 310022 310023 310026 310032 310039 310096 310105 310133 310135 310157 310160 310209 310210 310211 310212 310213 310214 310215 310216 310217 310218 310219 310220 310221 310222 310223 310224 310225 310226 310227 310228 310229 310230 310231 310232 310233 310234 310236 310237 310238 310239 310240 310241 310242 310243 310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256 310257 310258 310259 310260 310261 310262 310263 310264 310265 310266 310267 310269 310270 310271 310272 310273 310274 310275 310276 310277 310278 310279 310280 310281 310282 310283 310284 310285 310287 310288 310289 310290 310291 333002 333005 333010 333015 333018 333021 333042 333043 333051 333060 333061 333106 333107 333108 333109 333110 333112 333114 333115 333116 333117 333121 52035 333068 33084 52007 52008 52010 52013 52014 52019 52021 52024 52025 52026 52

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-2383-2016%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.