Siemens Uroskop Omnia Max X-Ray System Software Data Loss Recall
Siemens is recalling 133 Uroskop Omnia Max X-ray systems due to software defects that cause image deletion and connection issues.
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 involves data loss and operational errors rather than direct physical injury or death, fitting the criteria for moderate severity involving low-risk operational issues.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 133 units of the Uroskop Omnia Max, a solid-state detector fluoroscopic X-ray system used primarily for urological applications. The recall is due to software defects in version VE10E that can result in the deletion of studies and acquired images, requiring acquisitions to be repeated. Additionally, the system experiences sporadic connection issues with portable detectors (MAX wi-D, MAX mini) during image recovery.
The software issues are triggered by specific user actions, such as pressing the undo button on the RAD subtask card or the previous series button on the Image subtask card during image readout. The problems may also occur sporadically during automatic or manual RIS updates. The affected devices are identified by model number 10762473 and specific serial numbers listed in the recall documentation.
The recall covers devices distributed nationwide. Siemens is the recalling firm. Users should contact Siemens Medical Solutions USA, Inc. for further instructions regarding the software defect and necessary remediation steps.
The recalled product
- Product
- SIEMENS Uroskop Omnia Max ; a solid state detector fluoroscopic X-Ray system, primarily for urological applications (functional x-ray diagnostic, endourology and minimal invasive urology/surgery). The system,, which includes a radiologic/urologic treatment table, may be used for
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 133
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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