Siemens Uroskop Omnia Max system The Uroskop Omnia is a recall
Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications…
Why was Siemens Uroskop Omnia Max system The Uroskop Omnia is a 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 Uroskop Omnia Max system, material #s: 10762473, serial numbers: 4014 4015
- Product
- Siemens Uroskop Omnia Max system The Uroskop Omnia is a solid state detector fluoroscopic X-Ray system, primarily for urological applications…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 2
- 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)