Siemens ACUSON X700 Ultrasound System Recalled for Software Lockup
Siemens is recalling four ACUSON X700 ultrasound systems due to a software error that causes the system to lock up, requiring a reboot to recover operation.
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 explicitly states no injuries or illnesses have been reported. The hazard is a software lockup requiring a reboot, which fits the criteria for a moderate severity issue involving a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling four ACUSON X700 ultrasound systems equipped with software version 1.0.04. The affected units are identified by model numbers 10658844, 10658846, and 10658845, and specific serial numbers 356559, 356733, 356734, and 358714. These systems were distributed in Germany, the U.A.E., Hungary, and Brazil.
The recall is due to a communication error between the software and V5Ms transducers rotation function. This error causes the system to display an IMG_15 error message and lock up, requiring a reboot to recover system operation. The agency has classified this as a Class II recall.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the issue. The source text does not report any injuries or illnesses associated with this defect.
The recalled product
- Product
- ACUSON X700 Ultrasound System with software version 1.0.04. Model numbers: 10658844 ACUSON X700 Ultrasound System 10658846 - ACUSON X700 Ultrasound System (Russia) 10658845 - ACUSON X700 Ultrasound System (Korea) Radiology: The Siemens ACUSON X700 ultrasound imaging…
- Manufacturer
- Siemens Medical Solutions USA, Inc.
- Affected units
- 4
Distribution
Distribution scope not specified by the agency.
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