FDA Device recall Z-1875-2016
Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstructio…
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Ingenuity Computed Tomography X-ray Systems Product Usage: Intended to produce cross-sectional images of the body by computer reconstructio… 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-1875-2016 |
| 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 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. 728326; S/N: 300142 30003 30005 30006 30007 30008 30009 30010 30011 30012 30013 30014 30015 30017 30018 3001…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 |
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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-1875-2016%22
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