FDA Device recall Z-2385-2016

Ingenuity CT Model No. 728326

FDA Device
Class II
terminated
Published 2016-08-17

On 2016-08-17 the FDA classified a Class II recall of Ingenuity CT Model No. 728326 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-2385-2016
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 CT Model No. 728326; 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 CT Model No. 728326 S/N:300004 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 3001… Ingenuity CT Model No. 728326 S/N:300004 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 30017 30018 30019 30020 30021 30022 30025 30026 30027 30028 30029 30030 30031 30032 30033 30034 30036 30037 30038 30039 30040 30041 30042 30043 30044 30045 30046 32083 300015 300033 300037 300038 300045 300054 300057 300066 300068 300072 300081 300082 300084 300089 300091 300107 300109 300120 300122 300141 300142 300149 300150 300156 300157 300207 300208 300209 300210 300211 30004-132107 52060 300003 300005 300010 300011 300012 300013 300014 300016 300017 300018 300019 300020 300021 300022 300024 300025 300027 300028 300029 300030 300031 300032 300034 300035 300036 300039 300040 300041 300042 300043 300044 300047 300049 300050 300051 300052 300053 300055 300056 300058 300059 300060 300061 300062 300063 300064 300065 300069 300070 300071 300073 300074 300075 300077 300078 300079 300080 300083 300086 300087 300088 300090 300092 300093 300094 300095 300096 300097 3

code_info

Ingenuity CT Model No. 728326 S/N:300004 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 3001…

Ingenuity CT Model No. 728326 S/N:300004 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 30017 30018 30019 30020 30021 30022 30025 30026 30027 30028 30029 30030 30031 30032 30033 30034 30036 30037 30038 30039 30040 30041 30042 30043 30044 30045 30046 32083 300015 300033 300037 300038 300045 300054 300057 300066 300068 300072 300081 300082 300084 300089 300091 300107 300109 300120 300122 300141 300142 300149 300150 300156 300157 300207 300208 300209 300210 300211 30004-132107 52060 300003 300005 300010 300011 300012 300013 300014 300016 300017 300018 300019 300020 300021 300022 300024 300025 300027 300028 300029 300030 300031 300032 300034 300035 300036 300039 300040 300041 300042 300043 300044 300047 300049 300050 300051 300052 300053 300055 300056 300058 300059 300060 300061 300062 300063 300064 300065 300069 300070 300071 300073 300074 300075 300077 300078 300079 300080 300083 300086 300087 300088 300090 300092 300093 300094 300095 300096 300097 3

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-2385-2016%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.