FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis Zee Angiographic x-ray systems.
- Recall number
- Z-1309-2014
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis Zee Angiographic x-ray systems.
- Status
- Terminated
- Initiated
- 2014-02-07
- Posted
- 2014-03-31
- Terminated
- 2015-03-16
- Reason
- An inappropriate cable connection was assembled for certain Artis zee systems. which may cause a system failure and possibly lead to a restricted maneuverability of the gantry system.
- Root cause
- Device Design
- Action
- A recall notification letter dated February 7, 2014, was sent to End Users.
- Quantity
- 9
- Distribution
- MN, WI, PA, MI, AL, OH, NC, AR, and NJ.
- Lot, serial or model codes
- Model numbers: 10094135, 10094137, 10094139, 10094141, 10280959.
- 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