Siemens Luminos Agile Max Recalled for Software Bug Affecting Patient Images
Siemens is recalling 475 Luminos Agile Max devices due to a software bug that may assign one image to two patients, potentially affecting diagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm to patients through potential misdiagnosis, but no injuries or illnesses have been reported.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 475 units of the Luminos Agile Max, model no. 10762471. This device is intended to visualize anatomical structures by converting an X-ray pattern into a visible image for various medical examinations, including gastrointestinal, cranial, skeletal, thoracic, and urogenital tract studies.
The recall is due to a software bug that may lead to one image being assigned to two different patients. This error could potentially affect medical diagnosis. The affected units were distributed nationwide in the United States.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for instructions on how to resolve the software issue. Consumers are advised to check with their healthcare provider if they have had imaging performed on these devices.
The recalled product
- Product
- Luminos Agile Max, model no. 10762471 - Product Usage: Luminos Agile Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeleta
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Hazard
- Affected units
- 475
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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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