Drugs & medicalClass II

Canon Medical System, USA, INC. recalls Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron…

When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control…

Read the official notice →
Date
2024-11-13
Country
United States
Brand
Canon Medical System
Product
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission…
Classification
Class II
Units
US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VA
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 Details may be shortened or out of date; the official notice is the authoritative source.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

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  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 Canon Medical System recalls

  1. 2026-01-21
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    Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T Model MRT-3020/MEXL-3020

    There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed…

    FDA · DeviceCanon Medical System, USA, INC.U.S. Nationwide distribution in the states of CA, CO, FL, IA, IL, IN, KS, MD,…Official notice →
  3. 2025-11-05
  4. US
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    Canon Medical System, USA, INC. recalls VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7.

    Affected system contains components that do not meet the required distance between electrodes for compliance with the IEC 60601-1 standard for medical electrical equipment.

    FDA · DeviceCanon Medical System, USA, INC.US distribution to Ohio and NevadaOfficial notice →
  5. 2025-10-15
  6. US
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    Canon Medical System, USA, INC. recalls This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The…

    It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI, and the static image is overlayed around the ROI, covering the…

    FDA · DeviceCanon Medical System, USA, INC.U.S.Official notice →
  7. 2024-06-19
  8. US
    Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls MRI systems: Vantage Orian MRT-1550 (MEXL-1550), Vantage Elan MRT-2020 (MEXL-1520), Vantage Titan MRT-1504 (MEXL-1504), Vantage…

    The terminal block used to secure the power supply cable for the gradient coil of the MRI system was not secured as designed, which could cause cable disconnection, which could lead to arcing, followed by melting of…

    FDA · DeviceCanon Medical System, USA, INC.US: PA, SC, IA, AL, MI, AR, SD, TX, ID, KY, NY, MN, MD, OH, WI, NV, CT, AZ,…Official notice →
  9. 2024-03-13
  10. US
    Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls MRI system: Vantage Elan, Model: MRT-2020

    For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety…

    FDA · DeviceCanon Medical System, USA, INC.Worldwide - US Nationwide distribution including in the states of MD, IL, WV,…Official notice →
  11. 2024-02-28
  12. US
    Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls The INFX-8000F is designed to take advantage of the latest technological innovations to reduce dose and to save time. A…

    VAREX changed the manufacturing of the internal board, and the detectors displayed abnormal images. Internal board of the X-ray flat panel detector may display abnormal images, such as horizontal stripes, which may…

    FDA · DeviceCanon Medical System, USA, INC.US: CA, LAOfficial notice →
All 16 Canon Medical System recalls →

Other drugs & medical recalls in the United States

  1. 2024-11-13
  2. US
    Drugs & medicalClass II

    American Surgical Company, LLC recalls Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery. Ref:…

    Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from…

    FDA · DeviceAmerican Surgical Company, LLCCA, IA, IL, MN, MO, NY, OH, VA Foreign: Australia, Belgium, Hungry, Italy,…Official notice →
  3. US
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    Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515

    Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from…

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    Zimmer, Inc. recalls Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel…

    A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath…

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    Elekta Instrument AB recalls Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter / 14 Gauge, containing 6 inner boxes labeled REF…

    Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No…

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  6. US
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    Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA…

    Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

    FDA · DrugDirect RxNationwide in the USOfficial notice →
  7. US
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    Staska Pharmaceuticals, Inc. recalls Ascorbic Acid Inj. Solution, 25,000mg/50mL (500mg/mL), 50mL single use vial, Rx only, Staska Pharmaceuticals, 742 Evergreen Drive,…

    Presence of Particulate Matter: Presence of glass particulates.

    FDA · DrugStaska Pharmaceuticals, Inc.Nationwide in the USAOfficial notice →
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