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.
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, 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.
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 · data integrity
See all →- ModeratePhilips MR 7700 Software Upgrade Recalled for Incorrect DTI Data
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Blue Seal MRI Systems Recalled for DTI Export Errors
FDA (Devices) · 2026-10-07
- ModeratePhilips Ingenia Ambition MRI Systems Recalled for Incorrect DTI Data Exports
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
- SevereVolcano Corp Recalls Philips IntraSight Plus Systems Due to Data Error
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateSiemens ACUSON X700 Ultrasound System Recalled for Software Lockup
FDA (Devices) · 2016-05-04
- SevereSiemens Acuson SC2000 Ultrasound Systems Recalled for Inaccurate 3D Images
FDA (Devices) · 2013-10-30
- ModerateSiemens ACUSON SC2000 Ultrasound System Recalled for Data Capture Error
FDA (Devices) · 2015-09-23
- ModerateSiemens ACUSON SC2000 Ultrasound Systems Recalled for Software Display Errors
FDA (Devices) · 2014-06-04
- ModerateSiemens ACUSON S Family Ultrasound Systems Recalled for Measurement Error
FDA (Devices) · 2014-07-09
- HighSiemens Diagnostic Ultrasound Systems Recalled for Incorrect Unit Conversion
FDA (Devices) · 2024-10-02