Siemens Ysio Max Radiographic System Recalled for Software Data Loss
Siemens is recalling 133 Ysio Max radiographic systems because a software defect can delete acquired images and studies, requiring patients to repeat exposures.
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. The hazard involves data loss requiring repeated medical procedures, which is a significant operational and patient inconvenience but does not involve direct physical injury, death, or high-risk pathogens.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 133 units of the Ysio Max radiographic system. These devices are used in hospitals, clinics, and medical practices for radiographic and tomographic exposures of the whole body, including skull, chest, abdomen, and extremities. The systems are distributed nationwide.
The recall is due to a software defect in version VE10E that can cause studies and all acquired images to be deleted. Additionally, the connection with portable detectors (MAX wi-D, MAX mini) is sporadic during image recovery. The issue may occur when pressing the undo button on the RAD subtask card, the previous series button on the Image subtask card, or during automatic or manual RIS updates. As a result, acquisitions have to be repeated.
Healthcare facilities using the affected Ysio Max systems should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue. Patients who had imaging studies performed on these devices may need to repeat the examinations if their images were lost.
The recalled product
- Product
- SIEMENS Ysio Max; a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It c
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 133
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Model Number of device 10762470
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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