Siemens ACUSON S Family Ultrasound Systems Recalled for Image Display Defects
Siemens is recalling 2,045 ACUSON S Family ultrasound systems because the 18L6 HD transducer may display a triple image or a dark band, potentially affecting diagnostic accuracy.
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: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths. The hazard is a diagnostic image display defect (triple image or dark band) rather than a direct physical injury risk, fitting the criteria for a moderate severity recall involving potential adverse health consequences due to misdiagnosis or delayed diagnosis.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 2,045 ACUSON S Family ultrasound systems (models S1000, S2000, S2000 Refurb, and S3000) equipped with the 18L6 HD transducer and software versions VD10A or VD10C. The recall is due to a defect where the system may display a triple image or an image with a dark band when scanning with the affected transducer.
The triple image issue occurs because the system repeats one-third of the aperture without displaying the full field of view. This defect can compromise the integrity of the ultrasound images used for various medical applications, including fetal, abdominal, cardiac, and vascular imaging.
The affected systems were distributed worldwide, including in the United States and numerous international markets. Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue, which may involve software updates or other corrective actions to ensure accurate image display.
The recalled product
- Product
- 18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 2,045
Distribution
Distributed nationwide across the United States.
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 · image artifact
See all →- HighPET scanners recalled over a streaking artifact in clinical images
FDA (Devices) · 2026-01-28
- HighPhilips Incisive CT Scanner Software Issues May Cause Misdiagnosis
FDA (Devices) · 2024-01-17
- HighCT Scanner Software Error May Cause Scanning Interruptions and Unexpected Radiation
FDA (Devices) · 2022-04-27
- HighGE Healthcare Recalls CT Scanners Due to Potential Image Artifacts
FDA (Devices) · 2020-11-04
- HighUnited Imaging Recalls uEXPLORER PET/CT System for Potential Sharp Edges
FDA (Devices) · 2020-08-19
Similar recalls
- HighSiemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
FDA (Devices) · 2015-08-05
- ModerateSiemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors
FDA (Devices) · 2014-06-04
- HighSiemens ACUSON S Family Ultrasound Systems Recalled for Biopsy Guide Defect
FDA (Devices) · 2015-08-12
- ModerateSiemens Recalls Z6Ms Transesophageal Transducers Due to Material Deterioration
FDA (Devices) · 2016-12-07
- SevereSiemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images
FDA (Devices) · 2013-10-30
- HighSiemens ACUSON S2000 ABVS Scanner Recalled for Sharp Transducer Edges
FDA (Devices) · 2013-03-20