Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1165-2023.
Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1165-2023.
Recall ongoing. Follow firm instructions.
🩺 Talk to your doctor or pharmacist
Product Recall Tracker does not provide medical advice. Any specific instructions about this medication or device come directly from the FDA notice above. Before making any change to your treatment:
- Do not stop, change, or discard your prescription on your own.
- Call your doctor or pharmacist and ask whether this FDA notice applies to your prescription (have the brand name, dosage, and lot number ready if you can find them).
- Follow your clinician's guidance on whether to continue, switch, or return the product.
- If you have experienced a reaction, seek medical care and report it to the FDA via MedWatch.
- For the official FDA notice, visit the FDA recalls page.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-1165-2023.
Siemens Medical Solutions USA, Inc
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
Visit FDA.gov →📣 Report an adverse event to the FDA (MedWatch)
If you had an adverse reaction, side effect, or device malfunction from this medication or device, report it to the FDA through MedWatch. Talk to your doctor or pharmacist first — do not stop a prescription on your own. Reports help the FDA detect rare or emerging safety signals and can lead to label changes or recalls.
Siemens Medical Solutions Usa, Inc Recall FAQ
Siemens Medical Solutions Usa, Inc is the subject of a diagnostic devices safety report: Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic studies Model Number: 10762472. The notice was published on December 21, 2022 by the U.S. Food and Drug Administration (FDA). Approximately 28 units are potentially affected.