Drugs & medicalClass II

Siemens Medical Solutions USA, Inc recalls Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600

During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.

Read the official notice →
Date
2022-07-13
Country
United States
Brand
Siemens Medical Solutions
Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Classification
Class II
Units
Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2022-08-24
  2. US
    Drugs & medicalClass III

    Siemens Medical Solutions USA, Inc recalls AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; AXIOM Sensis, Hemo…

    The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide Distribution Foreign: Albania Algeria Angola Argentina Armenia…Official notice →
  3. 2022-07-27
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or…

    Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide Distribution AZ FL KY MI OH PR TXOfficial notice →
  5. 2022-07-13
  6. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

    It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are…

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →
  7. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:…

    After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide.Official notice →
  8. 2022-07-06
  9. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000

    A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This…

    FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Foreign distribution to Australia Austria…Official notice →
  10. 2022-06-15
  11. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Artis icono biplane -angiography systems developed for single and biplane diagnostic imaging and interventional procedures…

    if the protective earth is interrupted and an additional fault leads to a fault current, the detection of the fault current may not be ensured may cause an electric shock if a person is in contact with metallic parts…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide distribution.Official notice →
All 70 Siemens Medical Solutions recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-13
  2. US
    Drugs & medicalClass II

    Menarini Silicon Biosystems recalls CELLSEARCH Circulating Tumor Cell Kit (Epithelial)-IVD intended for the enumeration of circulating tumor cells (CTC) of epithelial…

    High number of total images/unassigned events including (dual positives) and the potential for false positive results being placed into the image gallery in some patient samples

    FDA · DeviceMenarini Silicon BiosystemsCA FL IL IN MA MI NC NM NY OH ON PA TX Foreign: Italy, Shanghai, Singapore,Official notice →
  3. US
    Drugs & medicalClass II

    Abbott recalls Abbott TactiCath Sensor Enabled, Contact Force Ablation Catheter, 8F 115cm FJ, REF A-TCSE-FJ. For mapping of the heart chambers during…

    When connected to the EnSite Precision Navigation System, an affected TactiCath Contact Force Ablation Catheter, Sensor Enabled may present the error message: "invalid catheter,, or "expired catheter."

    FDA · DeviceAbbottUS Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls Artis zeego (Model no. 10280959) and Artis Q.zeego (Model no. 10848283), Interventional Fluoroscopic X-Ray System

    It may occur that after system startup no stand movement is possible any longer in the event of a discharged BIOS battery of the robotic stand control PC. If this problem occurs during startup, all stand movements are…

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →
  5. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and…

    Positive bias with Lithium Heparin plasma samples from individuals that are expected to be below the 99th percentile of 0.07 ng/mL [0.07 ¿g/L], may lead to inappropriate intervention for myocardial infarction

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →
  6. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls syngo Application software VE20 (Material Number 10848815) installed on the Artis pheno and Artis icono systems as follows:…

    After CT image data from Toshiba is loaded, image mirroring can occur along the horizontal and vertical image axes. If this error occurs, the patient orientation/position may be misinterpreted and result in…

    FDA · DeviceSiemens Medical Solutions USA, IncUS Nationwide.Official notice →
  7. US
    Drugs & medicalClass II

    Rayner Intraocular Lenses Ltd recalls RayOne Preloaded Hydrophilic Acrylic IOL Injection Systems containing one MICS injection system with Intraocular Lens: (1) Outer…

    The outer package is mislabeled and the package contains a different IOL strength.

    FDA · DeviceRayner Intraocular Lenses LtdUS Nationwide distribution in the states of AZ, CA, FL, GA, IN, MI, MN, MO,…Official notice →
See all drugs & medical recalls →