Events

Recall of Device Recall Precision 500D

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
    65862
  • Event Risk Class
    Class 2
  • Event Number
    Z-1989-2013
  • Event Initiated Date
    2013-05-02
  • Event Date Posted
    2013-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120532
  • 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, fluoroscopic, image-intensified - Product Code JAA
  • Reason
    Ge healthcare has recently become aware of a potential safety issue involving the overhead video monitor suspension involving precision 500d systems. there is a potential for the locking nut to loosen out of the video monitor suspension yoke which could result in impact. this will not lead to an immediate fall of the suspended monitor since it will be held in place by the remaining bushing and.
  • Action
    GE Healthcare "Urgent Medical Device Correction" letter dated May 1, 2013 to all affected customers. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. The letter informed customers that GE Healthcare will correct all affected systems at no cost. A GE Healthcare service representative will contact you to arrange for this correction. For questions or concerns regarding this notification call: US 800-437-1171, Japan: 0120-055-919.

Device

Device Recall Precision 500D
  • Model / Serial
    FMI# 10879: CRT Monitor Suspension Supporting Hardware Serial 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  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the states of AL, AK, AR, CA, CO, CT, FL, GA, HI, ID, IL IN, IA, KS, KY, LA, MD, MA, NMI, MN, MS, MO, NE, NV,NH,NJ, NM, NY, NC,ND, OH, OK OR, PA,SC, SD, TN, TX, UT, VA, WA, WV, WI, WY and the countries of CANADA, FRANCE GERMANY, GREAT BRITAIN ITALY, PANAMA, SAUDI ARABIA.
  • Product Description
    GE Healthcare, Precision 500D || Product Usage: || The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
  • 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