FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
- Recall number
- Z-2257-2020
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
- Status
- Terminated
- Initiated
- 2020-04-23
- Posted
- not on file
- Terminated
- 2020-10-26
- Reason
- Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
- Root cause
- Software design
- Action
- Siemens issued Urgent Medical Device Correction (AX035/20/S) dated 4/23/20. The letter states reason for recall health risk and action to take: We urgently recommend not to use Quantification Application (QVA/QCA) on DSA images until the software problem has been resolved. If Quantification Application has already been used on DSA images in the past, please verify the results and diagnostic evaluation if applicable. Siemens will correct the error with a software patch via Update Instruction AX034/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.
- Quantity
- 5 US
- Distribution
- AZ, IL, UT, WI
- Lot, serial or model codes
- Serial Numbers: 180014 180015 180018 180019 180029
- 510(k) numbers
- ["K193326"]
- 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