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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73961

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

Open FDA event record

Event summary

Timeline bucket
April 08, 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

4 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 4

Brilliance 64 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1872-2016
Recall number
Z-1872-2016
Initiated
April 08, 2016
Classification
Class II
Status
Terminated
Quantity
158 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

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 became aware of a problem where the system may not map Varian drive after CT user logout/login.

Code information

Model No. 728231; S/N: 4001 5169 9056 9074 9099 9134 9251 9515 9529 9538 9541 9548 9549 9554 9559 9561 9573 9574 9600 9618 9625 9631 9638 9646 9653 9656 9659 9667 9670 9678 9686 9689 9703 9711 9738 9740 9755 9763 9782 9805 9811 9822 9833 9837 9838 9859 9862 9890 9898 9901 9909 9910 9917 9920 9922 9923 9927 9930 9933 9983 9989 9993 10012 10014 10021 10024 10042 10047 10050 10051 10077 10092 10099 10106 10150 10179 10180 10193 10206 10208 10213 10216 10250 10299 10302 10379 10394 10422 10446 10470 10514 10610 10671 10698 10743 29002 29014 29015 29056 29107 29115 90124 90154 91003 95022 95024 95130 95157 95191 95197 95213 95222 95236 95239 95244 95258 95261 95343 95349 95351 95364 95374 95387 95399 95409 95410 95439 95475 95496 95504 95507 95512 95524 95538 95551 95563 95614 95616 95668 95688 95691 95707 95811 122856 122863 122866 122877 122902 122921 122922 122953 123070 123092 123096 123116 123117 300062 95341A

Distribution pattern

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, 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 shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 2 of 4

Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1873-2016
Recall number
Z-1873-2016
Initiated
April 08, 2016
Classification
Class II
Status
Terminated
Quantity
300 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

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 became aware of a problem where the system may not map Varian drive after CT user logout/login.

Code information

Model No. 728321; S/N: 310135 310257 52035 333068 31001 33084 52000 52007 52008 52010 52012 52013 52014 52015 52018 52019 52020 52021 52022 52024 52025 52026 52027 52029 52030 52031 52032 52033 52034 52036 52037 52038 52039 52040 52041 52042 52043 52044 52045 52046 52047 52048 52050 52052 52053 52054 52055 52056 52057 52058 52059 52061 52063 52064 52065 52066 52067 52068 52069 52070 52071 52072 52075 52076 52077 52078 52079 52080 52081 132164 132465 300141 310001 310002 310003 310009 310017 310022 310023 310026 310032 310039 310042 310052 310054 310055 310059 310064 310069 310070 310071 310081 310087 310088 310090 310096 310098 310107 310111 310113 310119 310121 310129 310133 310134 310141 310143 310149 310151 310157 310159 310160 310170 310203 310204 310205 310206 310207 310208 310209 310210 310211 310212 310213 310214 310215 310216 310217 310218 310219 310220 310221 310222 310223 310224 310225 310226 310227 310228 310229 310230 310231 310232 310233 310234 310235 310236 310237 310238 310239 310240 310241 310242 310243 310245 310246 310247 310248 310249 310250 310252 310253 310254 310255 310256 310258 310259 310260 310261 310262 310263 310264 310265 310266 310267 310269 310270 310271 310272 310273 310274 310275 310276 310277 310278 310279 310280 310281 310282 310283 310284 310285 310286 310287 310288 310289 310290 310291 310292 310293 310294 310295 310296 310297 310299 310300 310301 310304 310308 333002 333004 333005 333009 333010 333014 333015 333018 333019 333021 333030 333031 333037 333042 333043 333044 333045 333046 333048 333049 333050 333051 333052 333053 333054 333055 333056 333059 333060 333061 333062 333063 333064 333065 333066 333067 333069 333070 333071 333072 333073 333074 333075 333076 333077 333078 333079 333080 333081 333082 333083 333085 333086 333087 333088 333089 333090 333091 333092 333093 333094 333095 333096 333097 333098 333099 333100 333101 333102 333103 333104 333105 333106 333107 333108 333109 333110 333111 333112 333113 333114 333115 333116 333117 333118 333119 333120 333121 333122 333123 333124.

Distribution pattern

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, 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 shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 3 of 4

Ingenuity Core 128 Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1874-2016
Recall number
Z-1874-2016
Initiated
April 08, 2016
Classification
Class II
Status
Terminated
Quantity
424 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

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 became aware of a problem where the system may not map Varian drive after CT user logout/login.

Code information

Model No. 728323; S/N: 320123 320240 30016 30023 30151 32000 32001 32008 32010 32012 32013 32015 32016 32018 32021 32024 32026 32028 32032 32033 32034 32036 32037 32041 32042 32043 32044 32046 32047 32048 32049 32050 32051 32052 32053 32054 32055 32056 32057 32058 32059 32060 32061 32062 32063 32064 32065 32067 32068 32069 32070 32071 32072 32073 32074 32075 32076 32077 32078 32079 32080 32081 32082 32084 32085 32086 32087 32088 32089 32090 32091 32092 32093 32094 32095 32096 32097 32098 32099 32100 32101 32102 32103 32104 32105 32106 32108 32109 32110 32111 32112 32113 32114 32115 32116 32117 32118 32119 32120 32121 32122 32123 32124 32125 32126 32127 32128 32129 32130 32131 32132 32133 32134 32135 32136 32137 32138 32139 32140 32141 32142 32143 32144 32145 32146 32147 32148 32149 32150 32151 32152 32153 32154 32155 32156 32157 32158 32159 32160 32161 32162 32163 32164 32165 32166 32167 32168 52023 52028 52049 52062 122928 320001 320002 320003 320005 320006 320008 320010 320018 320024 320026 320029 320030 320031 320033 320037 320054 320058 320059 320069 320073 320074 320078 320079 320081 320082 320083 320084 320088 320090 320092 320096 320099 320100 320101 320103 320107 320111 320114 320115 320119 320122 320125 320126 320128 320129 320131 320132 320133 320134 320138 320144 320146 320147 320200 320201 320202 320203 320204 320206 320207 320208 320209 320210 320211 320212 320213 320214 320215 320216 320217 320218 320219 320220 320221 320222 320223 320224 320225 320226 320227 320228 320229 320230 320231 320232 320233 320234 320235 320236 320237 320238 320239 320241 320242 320243 320245 320246 320247 320248 320250 320251 320252 320254 320255 320256 320257 320258 320260 320261 320262 320263 320264 320265 320266 320267 320268 320269 333047 336011 336012 336013 336015 336016 336017 336018 336023 336025 336027 336028 336029 336034 336040 336044 336046 336051 336059 336060 336064 336066 336067 336068 336069 336070 336071 336072 336073 336075 336076 336077 336078 336079 336080 336081 336082 336083 336084 336085 336086 336087 336088 336089 336090 336091 336092 336093 336094 336095 336096 336097 336098 336099 336100 336101 336102 336103 336104 336105 336106 336107 336108 336109 336110 336111 336112 336113 336114 336115 336116 336117 336118 336119 336120 336122 336123 336124 336125 336126 336127 336128 336129 336130 336131 336132 336133 336134 336135 336136 336137 336138 336139 336140 336141 336142 336143 336144 336145 336146 336147 336148 336149 336150 336151 336152 336153 336154 336155 336156 336157 336158 336159 336160 336161 336162 336163 336164 336165 336166 336167 336168 336169 336170 336171 336172 336173 336174 336175 336176 336177 336178 336180 336181 336182 336183 336184 336185 336186 336187 336188 336190 336191 336192 336193 336194 336195 336196 336197 336199 336200 336202 336203 336204 336206

Distribution pattern

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, 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 shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.

device · product 4 of 4

Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Z-1875-2016
Recall number
Z-1875-2016
Initiated
April 08, 2016
Classification
Class II
Status
Terminated
Quantity
215 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.

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 became aware of a problem where the system may not map Varian drive after CT user logout/login.

Code information

Model No. 728326; S/N: 300142 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 30017 30018 30019 30020 30021 30022 30025 30026 30027 30028 30029 30030 30031 30032 30033 30034 30035 30036 30037 30038 30039 30040 30041 30042 30043 30044 30045 30046 30049 32083 32107 52060 300003 300004 300005 300010 300011 300012 300013 300014 300015 300016 300017 300018 300019 300020 300021 300022 300024 300025 300027 300028 300029 300030 300031 300032 300033 300034 300035 300036 300037 300038 300039 300040 300041 300042 300043 300044 300045 300047 300049 300050 300051 300052 300053 300054 300055 300056 300057 300058 300059 300060 300061 300062 300063 300064 300065 300066 300068 300069 300070 300071 300072 300073 300074 300075 300077 300078 300079 300080 300081 300082 300083 300084 300086 300087 300088 300089 300090 300091 300092 300093 300094 300095 300096 300097 300098 300099 300100 300101 300102 300103 300104 300105 300106 300107 300108 300109 300110 300111 300112 300113 300114 300115 300116 300117 300118 300119 300120 300121 300122 300123 300124 300125 300126 300127 300128 300129 300130 300131 300132 300133 300135 300136 300137 300138 300139 300140 300141 300143 300144 300145 300146 300147 300148 300149 300150 300151 300156 300157 300158 300159 300160 300161 300162 300163 300164 300165 300166 300200 300201 300202 300203 300204 300205 300206 300207 300208 300209 300210 300211 300212 310058 310144 320003 320205 333057 336061 336084 336121 941091 30004-1

Distribution pattern

Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, 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 shipped to the following countries: Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Brazil, Cambodia, China, Colombia, Cuba, Estonia, Finland, France, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Latvia, Lebanon, Libya, Lithuania, Malaysia, Myanmar, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, R¿union, Russian Federation, Senegal, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.