FDA Medical devices recall ·
ARTIS icono ceiling recall
- Recall number
- Z-2648-2026
- Date
- (initiated June 8, 2026)
- Company / brand
- Siemens Medical Solutions USA, Inc
40 Liberty Blvd, Malvern, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 57 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
ARTIS icono ceiling. Model Number: 11328100.
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: 11328100. UDI-DI: 4056869295923.
Distribution
US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
States: California Georgia Iowa Indiana Louisiana Missouri North Carolina New York Pennsylvania South Carolina
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2648-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.