Siemens Luminos Agile Max system The Luminos Agile is recall
Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies.…
Why was Siemens Luminos Agile Max system The Luminos Agile is recalled?
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
Siemens Luminos Agile Max system material #s: 10762472, with serial numbers: 61013 61015 61011 61014 61017
- Product
- Siemens Luminos Agile Max system The Luminos Agile is intended to be used as a universal imaging system for radiographic and fluoroscopic studies.…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 5
- Distribution
- Nationwide Distribution - US including UT, MO, CO, MA, MN, MS, OH, SC, MI, and NY.
- Recall date
- October 8, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)