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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73750

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

Open FDA event record

Event summary

Timeline bucket
March 24, 2016
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

7 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 7

Brilliance 64 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2366-2016
Recall number
Z-2366-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
318 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728231; Serial #s: 9009, 9029, 9033, 9037, 9038, 9043, 9045, 9051, 9052, 9056, 9058, 9064, 9065, 9067, 9068, 9070, 9072, 9073, 9075, 9086, 9089, 9092, 9104, 9105, 9106, 9107, 9108, 9112, 9120, 9139, 9151, 9152, 9156, 9190, 9243, 9259, 9502, 9503, 9504, 9507, 9508, 9511, 9512, 9515, 9516, 9522, 9525, 9526, 9529, 9530, 9531, 9533, 9534, 9545, 9547, 9550, 9551, 9556, 9561, 9564, 9572, 9577, 9580, 9584, 9591, 9594, 9596, 9598, 9603, 9606, 9607, 9608, 9612, 9613, 9614, 9618, 9620, 9624, 9625, 9626, 9628, 9630, 9633, 9634, 9635, 9639, 9640, 9641, 9642, 9646, 9648, 9650, 9655, 9663, 9666, 9667, 9672, 9676, 9678, 9685, 9686, 9690, 9691, 9692, 9694, 9695, 9697, 9700, 9705, 9706, 9709, 9713, 9716, 9726, 9729, 9732, 9735, 9736, 9738, 9740, 9750, 9751, 9752, 9753, 9754, 9757, 9759, 9760, 9761, 9775, 9777, 9780, 9781, 9788, 9790, 9793, 9794, 9802, 9805, 9809, 9811, 9812, 9821, 9823, 9826, 9830, 9833, 9835, 9843, 9846, 9855, 9857, 9860, 9861, 9866, 9869, 9870, 9873, 9875, 9876, 9878, 9879, 9881, 9882, 9885, 9888, 9889, 9890, 9894, 9895, 9902, 9906, 9910, 9916, 9917, 9918, 9924, 9936, 9937, 9938, 9942, 9948, 9951, 9954, 9960, 9961, 9965, 9966, 9968, 9969, 9974, 9975, 9978, 9980, 9982, 9985, 9992, 9993, 9994, 9999, 10001, 10005, 10014, 10018, 10026, 10030, 10031, 10035, 10036, 10037, 10041, 10045, 10046, 10051, 10054, 10065, 10067, 10070, 10072, 10079, 10080, 10085, 10086, 10094, 10095, 10096, 10098, 10103, 10111, 10112, 10113, 10120, 10122, 10125, 10141, 10148, 10190, 10194, 10200, 10202, 10203, 10211, 10224, 10256, 10263, 10291, 10292, 10310, 10332, 10353, 10359, 10363, 10365, 10370, 10371, 10372, 10373, 10380, 10381, 10386, 10388, 10413, 10417, 10424, 10426, 10473, 10486, 10505, 10513, 10527, 10535, 10561, 10570, 10645, 10651, 10655, 10673, 10686, 10733, 10743, 10773, 10776, 29005, 29007, 29016, 29018, 29025, 29027, 29035, 29037, 29053, 29054, 29068, 29097, 64015, 90031, 90047, 90062, 90063, 90128, 95003, 95008, 95022, 95057, 95058, 95068, 95149, 95197, 95210, 95348, 95357, 95377, 95392, 95403, 95811, 95341A, 9851T, 9172.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 2 of 7

Brilliance BigBore Oncology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2367-2016
Recall number
Z-2367-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
8 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728243; Serial #s: 7063, 7116, 7169, 7205, 7309, 7314, 7354, 7611.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 3 of 7

Brilliance BigBore Radiology Computed Tomography X-ray systems, intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2368-2016
Recall number
Z-2368-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
17 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728244; Serial #s: 7052, 7172, 7200, 7244, 7252, 7375, 7380, 7384, 7390, 7514, 7533, 7546, 7614, 7633, 7708, 7781, 7789.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 4 of 7

Brilliance 16 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2369-2016
Recall number
Z-2369-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
203 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728246; Serial #s: 3010, 3017, 3031, 3040, 3043, 3070, 3072, 3085, 3090, 3117, 3123, 3149, 3179, 3216, 3247, 3293, 3314, 3324, 3411, 3465, 3490, 5006, 5009, 5012, 5018, 5020, 5024, 5026, 5028, 5030, 5031, 5035, 5044, 5045, 5048, 5052, 5053, 5054, 5055, 5058, 5059, 5060, 5064, 5069, 5070, 5075, 5077, 5081, 5086, 5088, 5091, 5093, 5097, 5099, 5101, 5103, 5107, 5108, 5110, 5111, 5113, 5115, 5116, 5118, 5120, 5123, 5126, 5127, 5128, 5131, 5135, 5138, 5140, 5147, 5155, 5160, 5161, 5163, 5166, 5181, 5184, 5186, 5188, 5190, 5191, 5192, 5193, 5195, 5197, 5208, 5209, 5216, 5219, 5224, 5231, 5235, 5236, 5237, 5270, 5272, 5279, 5282, 5285, 5287, 5288, 5294, 5295, 5315, 5316, 5347, 5348, 5350, 5354, 5357, 5360, 5368, 5394, 5405, 5412, 5433, 5434, 5443, 5453, 5457, 5474, 5480, 5487, 5501, 5502, 5505, 5516, 5519, 5523, 5526, 5554, 5572, 5573, 5576, 5609, 5615, 5633, 5647, 5653, 5674, 5683, 5703, 5723, 5758, 5762, 5764, 5771, 5811, 5897, 5929, 5937, 5956, 5974, 5995, 6021, 6022, 6031, 6033, 6048, 6053, 6072, 6154, 6220, 6229, 6243, 6280, 6283, 6298, 6299, 6309, 6321, 6360, 6375, 6405, 6426, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6549, 6555, 6559, 30011, 30049, 30110, 32287, 32366, 50011, 50053, 50087, 50180, 50181, 5238A.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 5 of 7

Brilliance CT 16 Power Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2370-2016
Recall number
Z-2370-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
55 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728240; Serial #s: 3100, 3236, 5043, 5047, 5280, 5345, 5390, 5395, 5413, 5430, 5476, 5495, 5499, 5500, 5512, 6007, 6009, 6013, 6032, 6041, 6045, 6049, 6051, 6058, 6062, 6064, 6066, 6067, 6070, 6071, 6077, 6080, 6081, 6084, 6089, 6095, 6098, 6100, 6106, 6109, 6113, 6115, 6116, 6119, 6120, 6123, 6124, 6131, 6132, 6134, 6141, 6144, 6155, 6161, 6162.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 6 of 7

Ingenuity Core Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2371-2016
Recall number
Z-2371-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
29 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728321; Serial #s: 310004, 310005, 310012, 310016, 310020, 310021, 310027, 310028, 310033, 310034, 310041, 310044, 310045, 310057, 310061, 310065, 310072, 310074, 310076, 310077, 310078, 310094, 310099, 310100, 310103, 310105, 310117, 310120, 310135.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

device · product 7 of 7

Ingenuity Core 128 Computed Tomography X-ray systems is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-2372-2016
Recall number
Z-2372-2016
Initiated
March 24, 2016
Classification
Class II
Status
Terminated
Quantity
5 units

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
Software defect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Software defect causing intermittently slow response of Host.

Code information

Model #: 728323; Serial #s: 310067, 320002, 320004, 320053, 320056.

Distribution pattern

Product was sent to the following states: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WV & WY. Product was also sent to the following countries: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, Canada, China, Colombia, Cuba, Denmark, Djibouti, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Martinique, Mexico, Monaco, Mongolia, Mozambique, Myanmar, Netherlands, New Zealand, Norway, Oman, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Viet Nam.

Field note

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