Artis Q/Q.zen recall: Software Issue
Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and…
Why was Artis Q/Q.zen recalled?
Siemens initiated a corrective action to address two possible, mutually independent causes of a system defect related to the following: - In Artis Systems with A100 Plus or A100G generators, an attempt to resume operation following detection of a fault can result in the failure of a module in the high-voltage generator. - For biplane systems delivered with software version VD11B since April of this year, software problems in conjunction with graphics card may, in rare cases, result in the loss of image display in the examination room.
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?
Model # 10848280, 10848281, 10848282, 10848353, 10848354, 10848355
- Product
- Artis Q/Q.zen, Angiographic x-ray system Stand alone system The Artis systems are a family of dedicated angiography systems developed for single and…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 1,500 distributed Worldwide
- Distribution
- Nationwide Distribution
- Recall date
- January 18, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)