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…

Read the official notice →
Date
2022-07-27
Country
United States
Brand
Siemens Medical Solutions
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology…
Classification
Class II
Units
US Nationwide Distribution AZ FL KY MI OH PR TX
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2022-11-02
  2. US
    Drugs & medicalClass II

    Siemens Medical Solutions USA, Inc recalls ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000

    Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…

    FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Foreign distribution worldwide.Official notice →
  3. 2022-09-07
  4. US
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    Siemens Medical Solutions USA, Inc recalls Artis icono biplane- Model No. 11327600 Artis icono floor- Model No. 11327700

    Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will…

    FDA · DeviceSiemens Medical Solutions USA, IncWorldwide Distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice →
  5. 2022-08-24
  6. 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 →
  7. 2022-07-13
  8. 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 →
  9. US
    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.

    FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA,…Official notice →
  10. 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 →
All 70 Siemens Medical Solutions recalls →

Other drugs & medical recalls in the United States

  1. 2022-07-27
  2. US
    Drugs & medicalClass II

    GE Healthcare, LLC recalls SIGNA Premier magnetic resonance scanner, model 5748519.

    Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.

    FDA · DeviceGE Healthcare, LLCWorldwide distribution - US Nationwide distribution in the states of AL, AZ,…Official notice →
  3. US
    Drugs & medicalClass II

    Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.

    FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.Official notice →
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    GE Healthcare, LLC recalls GE Healthcare Avance CS2, Avance CS2 Pro Anesthesia Systems, Part #1009-9050-000; and Aisys CS2 Anesthesia Systems, Part # 1011-9050-000.

    The base of the anesthesia system can have a crack and could potentially fracture resulting in a tip or overbalance of the anesthesia system. This can result in potential injury if it falls on a person.

    FDA · DeviceGE Healthcare, LLCDistribution was made to AZ, CA, CO, CT, FL, IA, ID, IL, IN, KY, LA, MA, MD,…Official notice →
  5. US
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    Randox Laboratories Ltd. recalls Randox Cholesterol- For the quantitative in vitro determination of Cholesterol in serum and plasma. Catalog Number: CH2O0

    Product fails to meet the performance claims quoted on the kit insert: Manual Procedure when calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal…

    FDA · DeviceRandox Laboratories Ltd.Nationwide Distribution - MD, OR, PR, MT, WVOfficial notice →
  6. US
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    Randox Laboratories Ltd. recalls Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

    A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in…

    FDA · DeviceRandox Laboratories Ltd.US Nationwide distribution in the state of IL.Official notice →
  7. US
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    CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

    There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English…

    FDA · DeviceCooperSurgical, Inc.Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT,…Official notice →
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