FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
- Recall number
- Z-1119-2015
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis One; The Artis One is an angiography system developed for diagnostic interventional procedures including, but not limited to pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities. Additionally, angiographic procedures can be performed in the operating room, image guided surgery by x-ray, by image fusion, and by navigation systems.
- Status
- Terminated
- Initiated
- 2015-01-16
- Posted
- 2015-02-17
- Terminated
- 2015-04-21
- Reason
- The possibility exists that the monitor may fail and requires a power circle (shutdown and then power on) to resume operation. The problem is not systematic; but sporadic on single units.
- Root cause
- Process control
- Action
- Siemens notified their customer via Customer Safety Advisory Letter AX049/14/S, dated January 16, 2015, and has initiated a fix with Update Instruction AX048/14/S which will be completed by a Siemens service technician. Customers with questions should contact the Customer Care Center at 1-800-888-7436. For questions regarding this recall call 610-219-6300.
- Quantity
- 1
- Distribution
- Nationwide Distribution to MI only
- Lot, serial or model codes
- Model Number 10848600, serial number 82010
- 510(k) numbers
- ["K133580"]
- PMA numbers
- not on file
- Product code
- OWB
- 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