Siemens Artis Zee Angiography System Software May Prevent X-Ray Activation
Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Class II recall with no reported injuries or illnesses. The software malfunction causes a procedural delay rather than direct patient harm, meeting the criteria for Moderate severity.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 19 units of the Artis zee multi-purpose angiography system with software version VD12 used for diagnostic imaging and interventional procedures. The recalled units have specific serial numbers and were distributed across the United States.
The recalled systems have a software issue that may prevent x-ray activation when the source-to-image distance (SID) lift movement is activated and an x-ray is simultaneously requested. When this occurs, the system displays an error message stating "No x-ray, try again" and the x-ray cannot be generated, resulting in a short delay during the procedure.
Siemens Medical Solutions has implemented a correction for this issue. Healthcare facilities that own or operate one of the recalled systems should contact Siemens Medical Solutions USA, Inc. directly for guidance on obtaining the software update.
The recalled product
- Product
- Artis zee multi-purpose with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094139
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Affected units
- 19
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software malfunction
See all →- HighPhilips PIC iX Essentials Patient Information System Software Recall
FDA (Devices) · 2026-09-23
- HighPhilips Patient Information Center iX Software Malfunction Recall
FDA (Devices) · 2026-09-23
- HighAbbott Merlin pacemaker programmer may fail to terminate threshold test
FDA (Devices) · 2026-06-17
- HighMedtronic SynchroMed Flex Infusion Programmer Software Application
FDA (Devices) · 2026-05-20
- ModerateProtocol Configuration Tool software v1.3.0 for Hamilton AutoLys STAR
FDA (Devices) · 2026-04-29
Similar recalls
- ModerateSiemens Artis zee Angiographic X-ray System Software Recall
FDA (Devices) · 2017-04-26
- ModerateSiemens Artis zee Angiography System Software Recall
FDA (Devices) · 2014-12-10
- HighSiemens Artis Angiography Systems Software Error May Delay Clinical Treatment
FDA (Devices) · 2021-09-08
- HighSiemens Artis zee and zeego X-ray Systems Recalled for Radiation Release Issue
FDA (Devices) · 2014-10-01
- ModerateSiemens ARTIS zee and zeego X-ray Systems Recalled for Software Issue
FDA (Devices) · 2013-07-31
- ModerateSiemens Artis zee/zeego Systems Recalled for X-ray Locking Function Defect
FDA (Devices) · 2015-08-26