FDA Device recall Z-0289-2022
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
- FDA Device
- Class II
- terminated
- Published 2021-12-01
On 2021-12-01 the FDA classified a Class II recall of SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000 by Siemens Medical Solutions Usa, citing software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0289-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-08-30 |
| Published | 2021-12-01 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
Reason
software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur
Identifiers
| code_info | Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 1220…Serial Numbers: Serial Number 122022 122098 122062 122099 122121 122146 122054 122082 122080 122020 122164 122116 122008 122036 122029 122044 122172 122074 122075 122049 122141 122167 122156 122081 122126 122129 122090 122130 122089 122085 122037 122009 122163 122064 122038 122161 122168 122158 122144 122063 122086 122035 122041 122114 122107 122101 122108 122109 122162 122125 122011 122052 122034 122057 122145 122147 122106 122061 122051 122166 122170 122092 122004 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2022%22
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