FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
- Recall number
- Z-0523-2024
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
- Status
- Open, Classified
- Initiated
- 2023-10-17
- Posted
- 2023-12-09
- Terminated
- not on file
- Reason
- Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
- Root cause
- Component design/selection
- Action
- On October 17, 2023, the firm issued an URGENT MEDICAL DEVICE CORRECTION letter to affected customers. According to the firm's letter, as the unintended behavior is caused by thermal startup effects, its occurrence can be avoided by only switching off the system for a short time. The firm suggests keeping the system running (except during proposed weekly reboot) if availability for treatment of emergency patients is necessary. Please plan for up to half an hour warm-up time after switching on the system. The firm will contact affected customers to modify the mounting of the tube cover to mitigate the probability of occurrence of the issue. You may contact the firm's service organization for an earlier appointment at 1-800-888-7436.
- Quantity
- 38 worldwide, 11 US
- Distribution
- US Nationwide - Worldwide Distribution: Domestic distribution to FL GA IA IL IN MI MN MO MT PA TX. Foreign distribution to Australia Canada Switzerland China Germany Denmark Egypt Spain Finland United Kingdom Israel Netherlands Sweden South Africa
- Lot, serial or model codes
- UDI-DI 04056869295923 Serial Numbers: All SN's associated with material number 11328100
- 510(k) numbers
- ["K221516"]
- 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