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.
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 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.
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