FDA Device recall Z-0177-2016

Brilliance Big Bore (Oncology & Radiology) 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 Big Bore (Oncology & Radiology) 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-0177-2016
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 Big Bore (Oncology & Radiology) 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. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128,… Model No. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128, 7158, 7170, 7173, 7178, 7193, 7204, 7214, 7221, 7228, 7231, 7235, 7246, 7262, 7265, 7273, 7284, 7328, 7347, 7353, 7364, 7365, 7370, 7395, 7400, 7403, 7434, 7435, 7462, 7467, 7481, 7484, 7596, 7612, 7775, 7794, 7795, 7803, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7853, 7854, 7855, 7856, 7857, 7858, 7859, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7869, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7888, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7914, 7916, 7918, 7920, 7921, 7923, 7924, 7925, 7927, 7928, 7929, 7931, 7932, 7933, 7935, 7936, 7937, 7938, 7939, 7940, 7941, 7942, 7943, 7944, 7945, 7946, 7948, 7949, 7950, 7953, 7954, 7955, 7956, 7960, 7961, 7962, 7963, 7968, 7969, 7970, 7971, 7972, 7973, 7974, 7975, 7976, 7977, 7978, 7980, 7981, 7982, 7983, 7984, 7985,

code_info

Model No. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128,…

Model No. 728243; S/N: 7007, 7013, 7015, 7020, 7023, 7028, 7059, 7061, 7072, 7083, 7086, 7087, 7101, 7123, 7124, 7128, 7158, 7170, 7173, 7178, 7193, 7204, 7214, 7221, 7228, 7231, 7235, 7246, 7262, 7265, 7273, 7284, 7328, 7347, 7353, 7364, 7365, 7370, 7395, 7400, 7403, 7434, 7435, 7462, 7467, 7481, 7484, 7596, 7612, 7775, 7794, 7795, 7803, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7853, 7854, 7855, 7856, 7857, 7858, 7859, 7860, 7861, 7863, 7864, 7865, 7866, 7867, 7868, 7869, 7872, 7873, 7875, 7876, 7877, 7881, 7883, 7884, 7885, 7886, 7888, 7889, 7890, 7891, 7892, 7893, 7895, 7896, 7898, 7900, 7901, 7902, 7904, 7905, 7907, 7908, 7909, 7910, 7911, 7914, 7916, 7918, 7920, 7921, 7923, 7924, 7925, 7927, 7928, 7929, 7931, 7932, 7933, 7935, 7936, 7937, 7938, 7939, 7940, 7941, 7942, 7943, 7944, 7945, 7946, 7948, 7949, 7950, 7953, 7954, 7955, 7956, 7960, 7961, 7962, 7963, 7968, 7969, 7970, 7971, 7972, 7973, 7974, 7975, 7976, 7977, 7978, 7980, 7981, 7982, 7983, 7984, 7985,

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-0177-2016%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.