FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
- Recall number
- Z-2686-2017
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis zee,x-ray system, angiographic Artis zee is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis zee include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee systems can also support the acquisition of position triggered imaging for spatial data synthesis
- Status
- Terminated
- Initiated
- 2017-02-03
- Posted
- not on file
- Terminated
- 2017-10-24
- Reason
- Failures can result due to a component defect on Artis zee systems with an A100 Plus generator of a certain delivery lot and 2-focus Megalix Cat Plus tube unit.
- Root cause
- Component design/selection
- Action
- CDRH approved the CAP subject to the following conditions: 1. You completed this recall as of May 6, 2017. Report any failures regarding this recall immediately to the District Recall Coordinator. 2. If this recall is expanded to include any additional consignees, models, or end users, any future customer notification letters to be sent must comply with the requirements of 21 CFR 1003.21. This includes, but is not limited to, the prescribed packaging and the statement that you will remedy the defect or bring the product into compliance at no charge.
- Quantity
- 97 distributed worldwide, 12 distributed in United States
- Distribution
- Worldwide Distribution - US to AR, KS, MI, IA, IL, WI, MN, WV, OH, and NY
- Lot, serial or model codes
- Serial Numbers: 124081 124061 137662 137668 137391 148001 147871 154827 154847 153197 131101 154035
- 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