FDA Device recall Z-0173-2016

Brilliance 16-Slice (Air) 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 16-Slice (Air) 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-0173-2016
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 16-Slice (Air) 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. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067,… Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067, 5068, 5072, 5073, 5094, 5097, 5143, 5169, 5174, 5223, 5249, 5297, 5317, 5368, 5439, 5546, 5638, 5663, 5703, 5728, 5740, 5741, 5916, 5928, 5971, 6028, 6030, 6052, 6061, 6067, 6070, 6085, 6090, 6107, 6111, 6117, 6133, 6147, 6153, 6156, 6161, 6162, 6231, 6255, 6491, 6556, 657, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6674, 6675, 6676, 6677, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706,

code_info

Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067,…

Model No. 728246; S/N: 3007, 3016, 3047, 3095, 3127, 3331, 3359, 3410, 3478, 3482, 3500, 3679, 3702, 4042, 5049, 5067, 5068, 5072, 5073, 5094, 5097, 5143, 5169, 5174, 5223, 5249, 5297, 5317, 5368, 5439, 5546, 5638, 5663, 5703, 5728, 5740, 5741, 5916, 5928, 5971, 6028, 6030, 6052, 6061, 6067, 6070, 6085, 6090, 6107, 6111, 6117, 6133, 6147, 6153, 6156, 6161, 6162, 6231, 6255, 6491, 6556, 657, 6606, 6607, 6608, 6609, 6610, 6611, 6612, 6613, 6614, 6615, 6616, 6617, 6618, 6619, 6620, 6621, 6622, 6623, 6624, 6625, 6626, 6627, 6628, 6629, 6630, 6631, 6632, 6633, 6634, 6635, 6636, 6637, 6638, 6639, 6640, 6641, 6642, 6643, 6644, 6645, 6646, 6647, 6648, 6649, 6650, 6651, 6652, 6653, 6654, 6655, 6656, 6657, 6658, 6659, 6660, 6661, 6662, 6663, 6664, 6665, 6666, 6667, 6668, 6669, 6670, 6671, 6672, 6673, 6674, 6675, 6676, 6677, 6678, 6679, 6680, 6681, 6682, 6683, 6684, 6685, 6686, 6687, 6688, 6689, 6690, 6691, 6692, 6693, 6694, 6695, 6696, 6697, 6698, 6699, 6700, 6701, 6702, 6703, 6704, 6705, 6706,

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-0173-2016%22

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