Siemens Recalls 80 ARTISTE MV Systems for Software Update
Siemens Medical Solutions is voluntarily recalling 80 ARTISTE MV Systems to install a software update. The devices were distributed throughout the United States.
What this means for you
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: The recall is classified as FDA Class II and is a voluntary, firm-initiated action for a software update with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Medical Solutions USA, Inc. is voluntarily recalling 80 units of the ARTISTE MV System (Device Model# 8139789). The recall was initiated on February 14, 2017, and was classified as Class II by the FDA. The reason for the recall is to install a software update.
The affected devices were distributed throughout the United States. The recall was initiated by the firm and was terminated on December 18, 2017. Initial notification to facilities was sent via letter.
This recall involves a software update for medical imaging equipment. No specific injuries, illnesses, or deaths are reported in the source text. The recall status is currently terminated.
The recalled product
- Product
- ARTISTE" MV System
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging System
- Hazard
- Affected units
- 80
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Device Model# 8139789
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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 4 products in this recall →Related recalls
Same manufacturer · Siemens Medical Solutions USA, Inc
See all →- HighARTIS icono floor Medical Imaging System Detector Movement Loss Recall
FDA (Devices) · 2026-07-08
- HighARTIS Icono Ceiling Model 11328100 Loss of Movement Capability Recall
FDA (Devices) · 2026-07-08
- ModerateARTIS icono biplane medical imaging system detector lift malfunction
FDA (Devices) · 2026-07-08
- ModerateARTIS icono ceiling medical imaging monitor suspension system
FDA (Devices) · 2026-07-08
- HighARTIS pheno systems may display zero dose while dose is applied
FDA (Devices) · 2026-06-10
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25