FDA Device recall Z-0174-2016

Brilliance 64 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 Brilliance 64 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-0174-2016
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

Brilliance 64 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. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 999… Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 9999, 10009, 10066, 10196, 10804, 10807, 29009, 29039, 29047, 29049, 29051, 29070, 29135, 29151, 90035, 90056, 90069, 90085, 90156, 90189, 90192, 95054, 95120, 95138, 95164, 95259, 95285, 95345, 95350, 95359, 95403, 95441, 95442, 95470, 95480, 95497, 95498, 95502, 95517, 95521, 95522, 95561, 95633, 95643, 95656, 95695, 95884, 95885, 95886, 95889, 95893, 95894, 95896, 95897, 95898, 95899, 95900, 95901, 95902, 95903, 95904, 95905, 95906, 95907, 95908, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95916, 95917, 95918, 95919, 95920, 95921, 95922, 95923, 95924, 95925, 95926, 95927, 95928, 95929, 95930, 95931, 95933, 95934, 95936, 95937, 95938, 95940, 95941, 95942, 95944 & 95946.

code_info

Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 999…

Model No. 728231; S/N: 2, 9030, 9047, 9050, 9152, 9168, 9234, 9250, 9542, 9552, 9627, 9664, 9690, 9801, 9915, 9996, 9999, 10009, 10066, 10196, 10804, 10807, 29009, 29039, 29047, 29049, 29051, 29070, 29135, 29151, 90035, 90056, 90069, 90085, 90156, 90189, 90192, 95054, 95120, 95138, 95164, 95259, 95285, 95345, 95350, 95359, 95403, 95441, 95442, 95470, 95480, 95497, 95498, 95502, 95517, 95521, 95522, 95561, 95633, 95643, 95656, 95695, 95884, 95885, 95886, 95889, 95893, 95894, 95896, 95897, 95898, 95899, 95900, 95901, 95902, 95903, 95904, 95905, 95906, 95907, 95908, 95909, 95910, 95911, 95912, 95913, 95914, 95915, 95916, 95917, 95918, 95919, 95920, 95921, 95922, 95923, 95924, 95925, 95926, 95927, 95928, 95929, 95930, 95931, 95933, 95934, 95936, 95937, 95938, 95940, 95941, 95942, 95944 & 95946.

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-0174-2016%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.