Events

Recall of Discovery NM/CT 570 c

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Healthcare, LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65797
  • Event Risk Class
    Class 2
  • Event Number
    Z-1967-2013
  • Event Initiated Date
    2013-04-10
  • Event Date Posted
    2013-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120193
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, tomography, computed, emission - Product Code KPS
  • Reason
    Ge healthcare has recently become aware of an incident where the wrong part of the patient body was scanned during a ct standalone exam with the discovery nm/ct 570c.
  • Action
    GE Healthcare will remedy the issue or bring the product into compliance with each applicable Federal standard. GE Healthcare has provided field modification instructions (FMI) to update software for the Discovery NM/CT570c hybrid system. The software update will correct the incorrect positioning of the table not prescribed by the operator. The FMI includes: A software upgrade with foreign language support to be installed in the affected models listed above, Labels (FMI label and packing label), Software upgrade workflow procedure with functional verification for all modes of operation, and Certification Report, Postponement of Medical Device Correction, Rejection of Medical Device Correction, or Refusal and/or Location Unknown Documentation. For further questions please call (262) 513-4122.

Device

Discovery NM/CT 570 c
  • Model / Serial
    Part numbers H3000SA UFC Cardiac SPECT System, H3001JA UFC Gantry, H3001JE UFC VCT Connecting Kit, H3001JF DISCOVERY NMV/CT 570C Connecting Kit.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution in the state of CT.
  • Product Description
    The Discovery NM/CT 570c CT Standalone Scan || The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications, head and body CT diagnostic imaging applications, as well as attenuation correction and anatomical localization. The Discovery product is a SPECT-CT system. It consists of two back-to-back gantries, the NM Gantry, carrying solid state Cadmium Zinc Telluride (CZT) detectors, the CT Gantry, a single patient table, power distribution unit (PDU), NMV integrated power supply (IPS) , two operator consoles with two acquisition systems (Nuclear and CT), interconnecting cables and associated accessories (ECG gating, etc.).
  • Manufacturer
    GE Healthcare, LLC

Manufacturer

GE Healthcare, LLC
  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA