FDA Device recall Z-2308-2018
Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures
- FDA Device
- Class II
- terminated
- Published 2018-07-04
On 2018-07-04 the FDA classified a Class II recall of Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures by Siemens Medical Solutions Usa, citing after the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2308-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-01 |
| Published | 2018-07-04 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
Product
Artis zee biplane, Material no. 10094141, for angiography and whole body radiographic/fluoroscopic procedures.
Reason
After the Large Display returns from power save mode, it may not show an image, and stay black without showing an error message although X-ray is still possible. The problem does not occur during an ongoing procedure. If the problem occurs, the system cannot be operated normally. It may be necessary to cancel or restart the treatment or transfer the patient to an alternate or another system.
Identifiers
| code_info | 153992 154616 154551 154536 154096 154532 154157 154571 154074 154012 154612 153274 154090 154567 154480…153992 154616 154551 154536 154096 154532 154157 154571 154074 154012 154612 153274 154090 154567 154480 154093 154502 154408 153987 154509 154079 154462 154098 154073 154076 153959 154653 154671 154556 153869 154633 154058 154155 154453 154579 154034 154560 154596 153708 153248 154048 153903 153819 154087 154606 154604 154581 154423 154546 154052 154501 154514 154562 154056 153999 154631 154089 154476 131020 154584 154610 153607 153886 154576 154602 154572 154564 153744 |
|---|
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-2308-2018%22
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