FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, INC: Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
- Recall number
- Z-0614-2018
- Recalling firm
- Siemens Medical Solutions USA, INC
- Product
- Artis oneFloor-mounted system for uncompromised imaging; Artis one, Interventional fluoroscopic x-ray system, Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. X-ray generator POLYDOROS A100 Plus
- Status
- Terminated
- Initiated
- 2017-08-22
- Posted
- not on file
- Terminated
- 2018-08-21
- Reason
- The possibility exists for the monitor display of Artis one systems with a DP Transceiver below revision 03 to experience blinking and/or a blue/black screen
- Root cause
- Nonconforming Material/Component
- Action
- Siemens sent an Urgent- Medical Device Correction letter dated August 22, 2017. Our service organization will contact you shortly to arrange a date to perform this corrective action (A system hardware update will be implemented and all affected DP Transceivers below revision 03 will be updated). Following the system hardware update, the cause is eliminated and a recurrence of the fault is prevented. For further questions, please call (610) 448-6461.
- Quantity
- 207 worldwide (13 distributed in US)
- Distribution
- US Distribution to the states of : AR, MO, NY, IN, AR, TX , NC, PA, MI, LA, WA, CA and AL.
- Lot, serial or model codes
- Serial # 82044; 82105; 82070; 82054; 82040;82038;82065 82108; 82010; 82039; 82109 82102 82066
- 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