Siemens ACUSON X700 Ultrasound Systems Recalled for Data Error
Siemens is recalling 490 ACUSON X700 ultrasound systems because previous patient data may replace current patient dates in reports.
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, but the hazard is a data integrity error (incorrect date in reports) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving minor errors or low-risk issues.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 490 ACUSON X700 Ultrasound Systems. The affected units are equipped with software versions 1.0.00, 1.0.01, 1.0.02, 1.1.00, or 1.1.02. The systems were distributed worldwide, including in the United States and numerous international markets.
The recall is due to a software defect that can occur when fourSight 4D ultrasound imaging, 3-Scrape real time 3D imaging, or Anatomical M-mode are used during an Obstetric or Gynecology study. In these instances, data from a previous patient could replace the current patient's date in the report. This error may lead to incorrect documentation of patient data.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Siemens ACUSON X700 Ultrasound Systems with software version 1.0.00, 1.0.01, 1.0.02, 1.1.00 and 1.1.02. ultrasound imaging system.
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 490
Distribution
Distributed nationwide across the United States.
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