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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72282

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 14, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Philips Medical Systems (Cleveland) Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Z-0173-2016
Recall number
Z-0173-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
323 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered Ring/Dot artifact due to X-ray measurement error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, 6707, 6708, 6709, 6710, 6711, 6712, 6713, 6714, 6715, 6716, 6717, 6718, 6719, 6720, 6721, 6722, 6723, 6724, 6725, 6726, 6727, 6728, 6729, 6730, 6731, 6732, 6733, 6734, 6735, 6736, 6737, 6738, 6740, 6741, 6742, 6743, 6744, 6745, 6746, 6747, 6748, 6749, 6750, 6751, 6752, 6753, 6754, 6755, 6756, 6757, 6758, 6759, 6760, 6761, 6762, 6763, 6764, 6765, 6766, 6767, 6768, 6769, 6770, 6771, 6772, 6773, 6774, 6775, 6776, 6777, 6778, 6779, 6780, 6781, 6782, 6783, 6784, 30033, 30049, 30063, 30070, 30075, 30103, 30115, 30123, 40013, 40018, 50026, 50043, 50068, 50177, 50182, 50189, 50195, 50198, 50200, 50213, 50216, 50217, 50218, 50219, 50220, 50221, 50222, 50223, 50224, 50225, 50226, 50227, 50228, 260010, 260011, 260013, 260014, 260015, 260016, 260017, 260018, 260032, 260033, 260035, 260036, 260037, 260038, 260039, 260047, 260048, 260049, 260050, 260051, 260052, 260053, 260054, 260055, 260056, 260057, 260058, 260059, 260060, 260061, 260062, 260063, 260064, 260065, 260066, 260067, 260068, 260069, 260070, 260071, 260072, 260073, 260074, 260075, 260076, 260077, 260078, 260079, 260080, 260081, 260082, 260083, 260084, 260085, 260086, 260087, 260088, 260089 & 260090.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 2 of 6

Brilliance 64 Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Z-0174-2016
Recall number
Z-0174-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
108 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered Ring/Dot artifact due to X-ray measurement error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 3 of 6

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

Z-0175-2016
Recall number
Z-0175-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered Ring/Dot artifact due to X-ray measurement error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. 728321; S/N: 52000, 52001, 52002, 52003, 52004, 52006, 52009, 52011, 52012, 52015, 52016, 52017, 52020, 52022, 52025, 52027, 52029, 310116, 310150, 310152, 310153, 310154, 310155, 310156, 310158, 310161, 310162, 310163, 310164, 310166, 310171, 333013, 333026, 333027, 333028, 333032, 333035, 333036, 333037, 333038, 333039 &333042.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 4 of 6

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

Z-0176-2016
Recall number
Z-0176-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
109 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered Ring/Dot artifact due to X-ray measurement error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 5 of 6

Brilliance Big Bore (Oncology & Radiology) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.

Z-0177-2016
Recall number
Z-0177-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
268 units total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered Ring/Dot artifact due to X-ray measurement error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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, 7987, 7989, 7990, 7991, 7992, 7993, 7994, 7995, 7996, 7997, 7998, 7999, 8000, 8001, 8002, 8004, 8005, 8006, 8007, 75002, 75003, 75004, 75005, 75006, 75007, 75008, 75009, 75010, 75011, 75012, 75013, 75014, 75015, 75016, 75017, 75018, 75019, 75020, 75021, 75022, 75023, 75024, 75025, 75026, 75027, 75028, 75029, 75031, 75032, 75033, 75034, 75035, 75036, 75037, 75039, 75040, 75041, 75042, 75043, 75044, 75046, 75047, 75048, 75049, 75050, 75054, 75060, 75065, 75100, 75102, 75104, 75108 & 750002. Model No. 728244; S/N: 7121, 7176, 7271, 7595, 7764, 7844, 7845, 7862, 7870, 7871, 7874, 7878, 7879, 7880, 7882, 7887, 7894, 7897, 7899, 7903, 7906, 7912, 7913, 7915, 7917, 7919, 7922, 7926, 7930, 7934, 7952, 7957, 7958, 7959, 7964, 7965, 7967, 7979, 7981, 7986, 7988, 75106 & 75110.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 6 of 6

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

Z-0178-2016
Recall number
Z-0178-2016
Initiated
September 14, 2015
Classification
Class II
Status
Terminated
Quantity
67 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered Ring/Dot artifact due to X-ray measurement error.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

Model No. 728317; S/N: 1, 78807, 260002, 260003, 340002, 340003, 345001, 345002, 345003, 345004, 345005, 345006, 345007, 345010, 345012, 345013, 345014, 345016, 345017, 345018, 345019, 345021, 345022, 345023, 345024, 345025, 345026, 345027, 345028, 345029, 345031, 345032, 345033, 345034, 345035, 345036, 345037, 345038, 345039, 345040, 345041, 345042, 345043, 345044, 345045, 345046, 345048, 345049, 345051, 345201, 345202, 345203, 345204, 345205, 345206, 345207, 345208, 345209, 345210, 345211, 345212, 345213, 345214, 345215, 345216, 345217, 345219, 345222, 345224 & 345228.

Distribution pattern

Worldwide Distribution-US (nationwide) including DC and the states of AL, AR, AS, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NH, NJ, NV, NY, OH, OK, OR, SC, TN, TX, UT, VA, VT, WI & WV, and the countries of Albania, Algeria, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Ecuador, Egypt, Ethiopia, Finland, France, Germany, Hong Kong, India, Indonesia, Iran, Iraq, Italy, Japan, Jordan, Kazakhstan, Latvia, Lebanon, Libya, Lithuania, Malaysia, Mexico, Mongolia, Myanmar, Netherlands, Nigeria, Norway, Oman, Panama, Philippines, Poland, Portugal, Romania, Russia, Rwanda, Samoa, Saudi Arabia, Singapore, South Korea, Spain, State of Palestine, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Field note

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