FDA Device recall Z-1354-2016

Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ra…

FDA Device
Class II
terminated
Published 2016-04-20

On 2016-04-20 the FDA classified a Class II recall of Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ra… by Philips Medical Systems Cleveland, citing the firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1354-2016
Classification	Class II
Status	terminated
Initiated	2016-02-05
Published	2016-04-20
Last updated	2026-09-13 11:54 UTC
Company	Philips Medical Systems Cleveland
Distribution	AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV

Product

Ingenuity Core Computed Tomography X-ray Systems, Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes

Reason

The firm was notified of a software error in which the system may not automatically send all image/data series to remote devices.

Identifiers

code_info	Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 3100… Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 310022, 310023, 310026, 310032, 310039, 310065, 310077, 310078, 310096, 310102, 310105, 310115, 310125, 310133, 310135, 310157, 310160, 310164, 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, 310292, 333002, 333005, 333008, 333010, 333015, 333018, 333021, 333042, 333043, 333051, 333060, 333061, 333064, 33310

code_info

Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 3100…

Model No. 728321; S/N: 31001, 52000, 52012, 52015, 52018, 52020, 52022, 52030, 52031, 52044, 52050, 52063, 310001, 310022, 310023, 310026, 310032, 310039, 310065, 310077, 310078, 310096, 310102, 310105, 310115, 310125, 310133, 310135, 310157, 310160, 310164, 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, 310292, 333002, 333005, 333008, 333010, 333015, 333018, 333021, 333042, 333043, 333051, 333060, 333061, 333064, 33310

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-1354-2016%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.