Drugs & medicalClass II

Siemens Medical Solutions USA, Inc recalls ARTIS icono ceiling. Model Number: 11328100.

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.

Read the official notice →
Date
2026-07-08
Country
United States
Brand
Siemens Medical Solutions
Product
ARTIS icono ceiling. Model Number: 11328100.
Classification
Class II
Units
US Nationwide distribution in the states of CA, GA, IA, IN, LA, MO, NC, NY,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Siemens Medical Solutions recalls

  1. 2026-07-08
  2. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS icono floor. Model Number: 11327700.

    Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits.

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution.Official notice →
  3. 2026-06-10
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane Model 11327600. ARTIS icono ceiling Model 11328100. ARTIS icono…

    During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame acquisitions. Despite the…

    FDA · DeviceSiemens Medical Solutions USA, IncUS and WorldwideOfficial notice →
  5. 2026-04-22
  6. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS Pheno VE30A and VE40A, Model 10849000

    During 3D acquisitions, lighter and darker patient images may be captured, which may result in less accurate 3D reconstruction. The variation of brightness is a result of a constant unregulated medium dose and the…

    FDA · DeviceSiemens Medical Solutions USA, IncU.S. and O.U.S.Official notice →
  7. 2026-04-15
  8. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS pheno and ARTIS Icono biplane, floor and ceiling. Model Numbers 10849000, 11327600, 11328100, 11327700.

    During patient examinations, the system may sporadically display a major increase of the x-ray dose applied to the patient. Despite the reported dose showing significantly higher, the actual applied x-ray dose levels…

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution.Official notice →
  9. 2026-02-11
  10. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Canada, Costa…Official notice →
  11. 2026-02-04
  12. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version…

    Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AK, CA, IL, MN, NY,…Official notice →
All 70 Siemens Medical Solutions recalls →

Other drugs & medical recalls in the United States

  1. 2026-07-08
  2. US
    Drugs & medicalClass II

    BD SWITZERLAND SARL recalls MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use

    Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.

    FDA · DeviceBD SWITZERLAND SARLU.S.: IL O.U.S: N/AOfficial notice →
  3. US
    Drugs & medicalClass II

    Covidien LLC recalls Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley…

    Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

    FDA · DeviceCovidien LLCU.S. Nationwide distribution including in the states and territories of AK,…Official notice →
  4. US
    Drugs & medicalClass II

    Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557

    Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.

    FDA · DeviceCarl Zeiss Meditec AGWorldwide - US Nationwide distribution in the state and territories of Florida…Official notice →
  5. US
    Drugs & medicalClass II

    RAYSEARCH LABORATORIES AB recalls RayCare 2024A SP1. Oncology Information Systems.

    Beam set delivery note issues in which there is potential data loss if the beam set delivery note is modified simultaneously and/or if a note is updated during a treatment session, the user is not notified of the change.

    FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide - US Nationwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    Medela Inc recalls Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A…

    May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

    FDA · DeviceMedela IncUS distribution to the following states: AZ, CA, CO, FL, HI, IL, IN, MD, MI,…Official notice →
  7. US
    Drugs & medicalClass II

    Accuray Incorporated recalls Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collimator Changer; Linear Accelerator

    In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents motion from the operator console. If personnel then enter the treatment room and initiate motion using the in-room…

    FDA · DeviceAccuray IncorporatedWorldwide - US Nationwide and and the countries of Australia, Austria,…Official notice →
See all drugs & medical recalls →