FDA Device recall Z-1873-2016
Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconst…
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Ingenuity Core Computed Tomography X-ray Systems, Product Usage: Intended to produce cross-sectional images of the body by computer reconst… by Philips Medical Systems Cleveland, citing the firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1873-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-04-08 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | US |
Product
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.
Reason
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Identifiers
| code_info | Model No. 728321; S/N: 310135 310257 52035 333068 31001 33084 52000 52007 52008 52010 52012 52013 52014 52015 52018 52…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 3 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1873-2016%22
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