FDA Device recall Z-0176-2016

Ingenuity Core 128 Computed Tomography X-ray systems

FDA Device
Class II
terminated
Published 2015-11-04

On 2015-11-04 the FDA classified a Class II recall of Ingenuity Core 128 Computed Tomography X-ray systems by Philips Medical Systems Cleveland, citing the firm discovered Ring/Dot artifact due to X-ray measurement error.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0176-2016
Classification	Class II
Status	terminated
Initiated	2015-09-14
Published	2015-11-04
Last updated	2026-09-13 11:53 UTC
Company	Philips Medical Systems Cleveland
Distribution	US

Product

Ingenuity Core 128 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Reason

The firm discovered Ring/Dot artifact due to X-ray measurement error.

Identifiers

code_info	Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019… Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141, 320142, 320143, 320145, 320148, 320149, 320150, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336045, 336047, 336048, 336049, 336050, 336051, 336052, 336053, 336055, 336056, 336057, 336058, 336063, 336065, 336069, 336074, 336701, 336702, 336703, 336704, 336705, 336706, 336707, 336708, 336709, 336710, 336711, 336712, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336720, 336721, 336722, 336723, 336724, 336725, 336726, 336727, 336728, 336729, 336730, 336731, 336732, 336733, 336734, 336735, 336736 & 336737.

code_info

Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019…

Model No. 728323; S/N: 30153, 32001, 32002, 32003, 32004, 32005, 32006, 32007, 32009, 32011, 32012, 32014, 32017, 32019, 32020, 32022, 32023, 32024, 32025, 32027, 32028, 32029, 32030, 32031, 32035, 32038, 32039, 32040, 32041, 32046, 32048, 32052, 32053, 32058, 32059, 32060, 32065, 32066, 320124, 320128, 320135, 320136, 320137, 320139, 320140, 320141, 320142, 320143, 320145, 320148, 320149, 320150, 336030, 336031, 336032, 336033, 336034, 336035, 336036, 336037, 336038, 336039, 336040, 336042, 336043, 336045, 336047, 336048, 336049, 336050, 336051, 336052, 336053, 336055, 336056, 336057, 336058, 336063, 336065, 336069, 336074, 336701, 336702, 336703, 336704, 336705, 336706, 336707, 336708, 336709, 336710, 336711, 336712, 336713, 336714, 336715, 336716, 336717, 336718, 336719, 336720, 336721, 336722, 336723, 336724, 336725, 336726, 336727, 336728, 336729, 336730, 336731, 336732, 336733, 336734, 336735, 336736 & 336737.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0176-2016%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.