FDA Device recall Z-0841-2018
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
- FDA Device
- Class II
- terminated
- Published 2018-03-14
On 2018-03-14 the FDA classified a Class II recall of IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System by Philips Medical Systems Cleveland, citing 23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0841-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-01-11 |
| Published | 2018-03-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | n/a |
Product
IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System
Reason
23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.
Identifiers
| code_info | Serial Numbers: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020…Serial Numbers: 860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860025 860026 860027 860028 860029 860030 860031 860032 860033 860034 860035 860036 860037 860038 860039 860040 860041 860042 860043 860046 860048 860049 860050 860051 860052 860053 860054 860055 860056 860057 860058 860059 860060 860061 860062 860063 860064 860065 860066 860067 860068 860070 860071 860072 890002 860047 |
|---|
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-0841-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.