Siemens Medical Imaging Systems Recalled for Image Loss and Labeling Errors
Siemens is recalling five Luminos Agile Max systems due to malfunctions that cause image loss and incorrect labels, leading to repeated examinations.
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 involves a risk-of-harm product (medical imaging system) where malfunctions lead to repeated examinations and potential misdiagnosis due to lost or mislabeled images, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling five Siemens Luminos Agile Max systems. These systems are intended for radiographic and fluoroscopic studies, including general radiography/fluoroscopy, angiography, and pediatric examinations. The recall covers specific serial numbers: 61013, 61015, 61011, 61014, and 61017, associated with material number 10762472.
The recall is due to two identified malfunctions that pose a potential risk to patients. An automatic Radiology Information System (RIS) worklist update can cause images to be lost, which results in examinations being repeated. Additionally, image labels may be displayed incorrectly after images are acquired. The affected units were distributed nationwide, including in Utah, Missouri, Colorado, Massachusetts, Minnesota, Mississippi, Ohio, South Carolina, Michigan, and New York.
Healthcare facilities should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address these malfunctions. Patients who have had examinations on these systems should consult their healthcare provider if they have concerns about image quality or labeling accuracy.
The recalled product
- Product
- Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies. Using either film cassettes or a digital mobile flat detector, it can perform a range of applications including general R/F, angiog
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Imaging Systems
- Hazard
- Affected units
- 5
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 (2)
- Siemens Luminos Agile Max system material #s: 10762472
- with serial numbers: 61013 61015 61011 61014 61017
Distribution
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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