FDA Medical Device Recalls (openFDA)
Siemens Medical Solutions USA, Inc: ARTIS icono ceiling. Model Number: 11328100.
- Recall number
- Z-2648-2026
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Product
- ARTIS icono ceiling. Model Number: 11328100.
- Status
- Open, Classified
- Initiated
- 2026-06-08
- Posted
- 2026-07-01
- Terminated
- not on file
- Reason
- Potential issue with the Display ceiling suspension (DCS Fix XL) that holds the monitor in place. Over time some screws that keep the monitor attached to the suspension may gradually loosen.
- Root cause
- Device Design
- Action
- Siemens Healthineers notified consignees on about 06/08/2026 via "CUSTOMER SAFETY ADVISORY NOTICE" letter. Consignees were instructed to conduct regular inspections of the gap between the monitor carrier and the ceiling-mounted arm and be attentive to any unusual noises, shaking, wobbling, or other unexpected behavior during system operation, as these may indicate loose screws. If any such signs are observed, limit movements of the DCS and contact Siemens service organization immediately for further instructions. Always ensure that the DCS is positioned for safe use. All affected systems will be corrected by Siemens Healthineers service engineers. Siemens engineers will correct the screwed connection of the monitor ceiling support according to the adapted specifications and instructions. The correction will be released via an Update Instruction AX022/26/S. Following the correction, the cause is eliminated, and any recurrence of this potential fault is prevented.
- Quantity
- 57 units
- Distribution
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
- Lot, serial or model codes
- Model Number: 11328100. UDI-DI: 4056869295923.
- 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