Luminos recall
LUMINOS Lotus Max (VF11)
Why was Luminos recalled?
Under certain unlikely circumstances during a fluoroscopic examination, the imaging system Fluorospot Compact might sporadically display an incorrect air kerma/air kerma rate related to the patient reference point, according to IEC 60601-2-43. There is no impact on workflow or diagnosis. The error can occur only in fluoroscopy systems with a second (overhead) X-ray tube.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model: 11574100
- Product
- LUMINOS Lotus Max (VF11)
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 704 units in the United States (1945 units worldwide)
- Distribution
- US Nationwide - Worldwide Distribution
- Recall date
- May 31, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)