FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis zee and Artis zeego systems. x-ray, angiographic system
- Recall number
- Z-2569-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis zee and Artis zeego systems. x-ray, angiographic system
- Status
- Terminated
- Initiated
- 2014-06-05
- Posted
- 2014-09-22
- Terminated
- 2015-04-21
- Reason
- There is a potential problem with Artis zee and Artis zeego systems running software version VC21B and being used in conjunction with the Large Display, in that under certain circumstances, the release of radiation can become blocked unnecessarily.
- Root cause
- Software design
- Action
- Siemens sent an "Important Customer Safety Notice" dated August 21, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please forward this Safety information to other organizations that could be affected by this measure. If the device has been sold and therefore no longer in your possession, please forward this safety notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this Customer Safety Notice and comply with the corresponding measures until the update has been fully completed. For further questions please call (610) 219-6300.
- Quantity
- 206
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- running software version VC21B 10094135, 10094137, 10094141, 10280959 with multiple serial numbers .
- 510(k) numbers
- ["K073290"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2240869
- Firm city
- Malvern
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28