FDAFDA recall Z-2648-2026 · Jul 8, 2026
Siemens Medical Solutions USA, Inc: ARTIS icono ceiling recall
Recall found
Product
ARTIS icono ceiling. Model Number: 11328100.
Reason for recall
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 to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Model Number: 11328100. UDI-DI: 4056869295923.
- Quantity
- 57 units
- Distribution
- US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY, PA, SC.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-06-08
Source: openFDA enforcement record Z-2648-2026 · search recall number Z-2648-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.