FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Recall number
- Z-1288-2021
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- Interventional Fluoroscopic X-Ray System - Product Usage: developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
- Status
- Terminated
- Initiated
- 2021-02-26
- Posted
- not on file
- Terminated
- 2021-08-11
- Reason
- Siemens has become aware of a potential issue in which the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem.
- Root cause
- Component design/selection
- Action
- On 2/26/2021, Siemens issued an Urgent Medical Device Correction notice to in inform customers of a possible hazard to patients, operators, or other persons and equipment due to a hardware error which affects ARTIS icono /pheno systems in combination with imaging system UPS (Uninterrupted Power Supply) option. This potential hardware issue has no influence on the previous treatment/diagnosis of patients. However, in case of error, planned procedures may have to be terminated and performed on an alternative x-ray system. Based on our investigation, you can continue to safely use your system.
- Quantity
- 29 systems
- Distribution
- US Nationwide distribution in the states of MI, KY, TX.
- Lot, serial or model codes
- ARTIS Icono biplane- 11327600 ARTIS Icono floor- 11327700
- 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