Siemens Medical Solutions USA, Inc. has recalled 796 units of the ACUSON Redwood 2.0 ultrasound system because of a software-related measurement defect. When using an 18L6 transducer with settings originally created on an older 1.0 system, the newer 2.0 system may display measurements that are smaller than they actually are while in 'Dual format' view. This defect could cause healthcare providers to misinterpret ultrasound results, leading to a wrong diagnosis or incorrect medical treatment for a patient. These systems are identified by software versions starting with 'VA20' and were distributed worldwide, including 28 U.S. states and territories.
The software error causes the ultrasound system to underestimate measurements during clinical exams. This inaccuracy can lead to serious medical errors, such as miscalculating the size of a lesion or organ, which may result in delayed or inappropriate patient management decisions.
Manufacturer correction via notification letter
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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