Canon Medical System, USA, INC. recalls Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and…
Due to the fixing screws of ceiling movement gear in ceiling suspended arm that are part of the X-ray interventional systems may become loose.
Read the official notice →- Date
- 2026-09-02
- Country
- United States
- Brand
- Canon Medical System
- Product
- Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, GA, MN, NC, NV, PA, OH, and…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2026-10-14
US
Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5
Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the state of ID.Official notice →- 2026-02-04
US
Canon Medical System, USA, INC. recalls Alphenix INFX-8000F, interventional fluoroscopic x-ray system
It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result,…
FDA · DeviceCanon Medical System, USA, INC.Worldwide distribution - US Nationwide and the country of Dominican Republic.Official notice →- 2026-01-21
US
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 →- 2025-11-05
US
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.
- 2025-10-15
US
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…
- 2024-11-13
US
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…
FDA · DeviceCanon Medical System, USA, INC.US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VAOfficial notice →
Other drugs & medical recalls in the United States
- 2026-09-02
US
ConMed Corporation recalls CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5…
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
US
Fresenius Medical Care Renal Therapies Group, LLC recalls Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T¿ BlueStar Hemodialysis machines.
FDA · DeviceFresenius Medical Care Renal Therapies Group, LLCUS Nationwide distribution.Official notice →US
Henry Schein Inc. recalls Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934,…
Specific lots were distributed in the US with incorrect packaging and Instructions for Use (IFU) from the U.S. FDA-cleared device.
FDA · DeviceHenry Schein Inc.Worldwide distribution - US Nationwide and the country of Barbados.Official notice →US
Midmark Corporation recalls Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Midmark IQecg Plugin versions starting with v10 and…
A communication anomoly may result in incorrect electrocardiogram waveforms of a patient and an inaccurate beats-per-minute calculation.
FDA · DeviceMidmark CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice →US
AVID Medical, Inc. recalls Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
US
Merge Healthcare, Inc. recalls Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Software issue may cause measurements to be displayed inaccurately.
FDA · DeviceMerge Healthcare, Inc.US Nationwide distribution in the states of California, Florida, Kentucky,…Official notice →