Recall Atlas
Drugs & medicalClass II

QUANTUM SURGICAL SAS recalls The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of…

Quantum Surgical has become aware that a component (central axis) inside the Needle Guide product (product number 02-0027) is the subject of rust.

Read the official notice →
Date
2024-10-16
Country
United States
Brand
Quantum Surgical
Product
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of…
Classification
Class II
Units
US Nationwide distribution in the state of FL.
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Quantum Surgical recalls

  1. 2025-06-18
  2. US
    Drugs & medicalClass II

    QUANTUM SURGICAL SAS recalls EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the…

    Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user.

    FDA · DeviceQUANTUM SURGICAL SASWorldwide distribution - U.S. Nationwide distribution in the states of FL,IL,…Official notice →
All 2 Quantum Surgical recalls →

Other drugs & medical recalls in the United States

  1. 2024-10-16
  2. US
    Drugs & medicalClass II

    Inspire Medical Systems Inc. recalls Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.

    Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

    FDA · DeviceInspire Medical Systems Inc.Worldwide distribution - US Nationwide and the countries of Belgium,…Official notice →
  3. US
    Drugs & medicalClass II

    GE Healthcare recalls GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Numbers: a)¿¿¿¿¿ 2089507-120; b)¿¿¿¿ 2089507-129;…

    GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (ZFP) version v6.0 SP11.x where the latest report is not shown by default to the user. The issue may occur when a study…

    FDA · DeviceGE HealthcareWorldwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    3M Company - Health Care Business recalls 3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R

    Contamination with foreign substance matter

    FDA · Device3M Company - Health Care BusinessInternational distribution to the country of South Korea.Official notice →
  5. US
    Drugs & medicalClass II

    Philips North America recalls Patient Information Center iX, Product Code 866386, and Patient Information Center iX Expand, Product Code 866390, Software Revision 4.0.1

    During extended operation of the MX40 with the PIC iX, the DHCP (Dynamic Host Configuration Protocol) lease can expire on the MX40. If the DHCP lease expires while the device is offline, upon reconnecting with the PIC…

    FDA · DevicePhilips North AmericaWorldwide - US Nationwide distribution.Official notice →
  6. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.

    It has been determined that certain Blood Pressure Monitors containing a faulty microchip have failed to power on or have shown display screen issues after the initial few uses, as well as overheating at times making…

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Panama and Jamaica.Official notice →
  7. US
    Drugs & medicalClass II

    Windstone Medical Packaging, Inc. recalls Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…

    Due to convenience kits containing a kit component that is under a recall action for improper use.

    FDA · DeviceWindstone Medical Packaging, Inc.U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Official notice →
See all drugs & medical recalls →