Artis systems - Product Usage: an angiography systems recall
Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but…
Why was Artis systems - Product Usage: an angiography systems recalled?
Due to inappropriate cleaning, some Artis systems show unexpected corrosion of visible belts which are needed to move system parts (e.g. C-Arm), Increased corrosion may lead to a malfunction of the belts which may result in limited functionality of the Artis system up to system failure. Unintended movement of the C-Arm may cause a hazardous situation to the patient, operator, or staff members and may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
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?
All serial numbers
- Product
- Artis systems - Product Usage: an angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but…
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3,320 units U.S.
- Distribution
- US Nationwide distribution.
- Recall date
- May 5, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)