Events

Recall of CT LightSpeed 16 and Discovery ST Pet/CT DST

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

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
    71167
  • Event Risk Class
    Class 2
  • Event Number
    Z-1623-2015
  • Event Initiated Date
    2015-04-22
  • Event Date Posted
    2015-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-07-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=136320
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Ge healthcare has become aware that 3 bolts that secure a power supply to the rotating side of the gantry were over-torqued on certain lightspeed 16 ct scanner or pet/ct dst scanner.. in the unlikely event that the component becomes loose on the ct gantry during operation, it could result in serious bodily injury if the component were expelled. there were no incidents or injuries reported as a res.
  • Action
    Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 25461 dated April 22, 2015. The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, and Radiologists/Cardiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter stated that customers can continue to use their device. If the error occurs, then stop using the system and call a service representative to bring the system back into proper operation. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative. UPDATED: Consignees were sent on 5/14/2015 a second GE Healthcare "Urgent Medical Device Correction" letter dated May 14th, 2015. The letter was to incorporate and additional unit being recalled.

Device

CT LightSpeed 16 and Discovery ST Pet/CT DST
  • Model / Serial
    Mfg Lot or Serial # System ID 00000331100CN8 904223CT 00000345975CN7 409838LS16 00000337343CN8 512OCCT  00000344962CN6 INSIGHTPCT1356
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to the states of MN, FL & TX.
  • Product Description
    CT LightSpeed 16 and Discovery ST Pet/CT DST. Catalogue # 2339985. || Designed to be a head and whole body CT scanner utilizing a new solid state detector.
  • Manufacturer
    GE Healthcare

Manufacturer

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