Artis zee recall: Software Issue
Artis zee, Angiographic x-ray system
Why was Artis zee recalled?
Software error - As a result of a software fault in Artis zee systems with software version VD11 and an A100 generator, the possibility exists that following the failure of a tube assembly focus, the Artis system functions properly until the next reactivation. Following reactivation, the system no longer initializes as intended.
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?
Device Model Numbers: 10280959, 10094137, 10094141, Serial numbers: 160449 147208, 153744
- Product
- Artis zee, Angiographic x-ray system
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 3 units distributed in U.S.
- Distribution
- Distributed to: VA, CA, WI
- Recall date
- April 26, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)