ARTIS icono ceiling 11328100Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04056869295923), received between Apr 15, 2026 and Apr 15, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

9 FDA recall records name this device's identifier, 9 still open.

7 other recalls cover devices cleared under the same FDA submission (K221516, K241572, K254173); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 8, 2026Open, Classified

   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.

   Z-2648-2026 · Root cause: Device Design · Recall details · FDA record ↗

2. May 20, 2026Open, Classified

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

   Z-2642-2026 · Root cause: Software design · Recall details · FDA record ↗

3. Mar 10, 2026Open, Classified

   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 are in accordance with the system settings and imaging conditions, as well as the applicable regulatory requirements.

   Z-1653-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

4. Mar 9, 2026Open, Classified

   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 reported x-ray dose showing 0, an actual x-ray dose is applied to the patient.

   Z-2206-2026 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

5. May 15, 2025Open, Classified

   In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorrectly report an application of a high dose.

   Z-2021-2025 · Root cause: Radiation Control for Health and Safety Act · Recall details · FDA record ↗

6. Jun 26, 2024Open, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2240-2024 · Root cause: Software design · Recall details · FDA record ↗

7. Jun 26, 2024Open, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2241-2024 · Root cause: Software design · Recall details · FDA record ↗

8. Jun 26, 2024Open, Classified

   A potential issue with ARTIS icono systems equipped with a small detector and a corresponding collimator (model # 10843101) was identified. In very rare situations, the first x-ray release following patient registration may be performed with incorrect copper prefiltration. If the described issue occurs, the applied radiation dose rate may be higher than intended by the user.

   Z-2242-2024 · Root cause: Software design · Recall details · FDA record ↗

9. Oct 17, 2023Open, Classified

   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.

   Z-0523-2024 · Root cause: Component design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2026Computer Software Problem; Activation Failure

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WITH THE ARTIS ICONO CEILING SYSTEM. DURING SYSTEM BOOTUP, IT WAS DETERMINED THAT STAND MOVEMENTS WERE NOT POSSIBLE, AND A STAND/TABLE ERROR MESSAGE WAS DISPLAYED TO THE USER. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24885278 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K221516, K241572, K254173. One submission often covers many models, so check the product and lot details in each record.

• Z-2641-2026 · May 20, 2026 · Open, Classified
  ARTIS icono biplane. Model Number: 11327600.
• Z-2643-2026 · May 20, 2026 · Open, Classified
  ARTIS icono floor. Model Number: 11327700.
• Z-1814-2026 · Mar 12, 2026 · Open, Classified
  ARTIS Pheno VE30A and VE40A, Model 10849000
• Z-2205-2026 · Mar 9, 2026 · Open, Classified
  ARTIS pheno, Model 10849000. interventional fluoroscopic x-ray system
• Z-2529-2025 · Aug 12, 2025 · Open, Classified
  Artis Pheno. Image-Intensified Flouroscopic X-Ray System.
• Z-2020-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system
• Z-2022-2025 · May 15, 2025 · Open, Classified
  interventional fluoroscopic x-ray system