FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis 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.
- Recall number
- Z-0469-2021
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Artis zee floor, Artis Q ceiling, Artis Q.zen ceiling. Image-Intensified Fluoroscopic X-Ray System. Material numbers 10848281, 10848354, 10094135, 10848354 - Product Usage: Artis 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.
- Status
- Terminated
- Initiated
- 2020-10-21
- Posted
- not on file
- Terminated
- 2021-05-05
- Reason
- Some electronic components within the generator were equipped with an incorrect protection diode. As a result, protection against overvoltage may be inadequate, and the system may not function properly in the event an overvoltage situation occurs.
- Root cause
- Employee error
- Action
- On October 21, 2020, the firm notified customers via Urgent Medical Device Correction letter. The letter informed customers of the hardware error, and that customers could continue to use their system but needed to follow their standard emergency procedures they had in place in the event of system failures. It is recommended to consider reinforcing these emergency procedures until the update has been completed. Siemens advises that an alternative system is available to continue treatment in case of occurrence. Siemens is implementing a corrective action to all affected users via Update Instruction AX018/20/S. The Siemens Service organization will exchange the affected printed circuit boards of the generator. This modification will bring the voltage back to the center of the tolerance range. Siemens' service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact the service organization for an earlier appointment at 1-800-888-7436. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
- Quantity
- 26 distributed worldwide (4 in US)
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AR, CA, IA, IL and the countries of China, Germany, India, Indonesia, Italy, Japan, Philippines, Saudi Arabia, South Korea, Taiwan, Turkey, and United Kingdom.
- Lot, serial or model codes
- Serial numbers 109762 111158 124344 111161
- 510(k) numbers
- ["K181407"]
- 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