Events

Recall of Device Recall GE Healthcare Precision RXi Digital system

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
    71574
  • Event Risk Class
    Class 2
  • Event Number
    Z-2122-2015
  • Event Initiated Date
    2015-06-12
  • Event Date Posted
    2015-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138743
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    A reported incident of a monitor that fell from the suspension. a fall of a monitor could result in an injury to a patient or operator. recall affects the single and dual lcd monitor suspensions used on precision 500d classical r & f system, precision rxi 23a/32a analog system, precision rxi digital system and precision mpi fluoroscopic imaging systems.
  • Action
    GE Healthcare sent an "Urgent Medical Device Correction" letter dated June 12, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Perform a visual check before and after each use for the presence of the four (4) mounting screws as shown in the pictures below. Check the secureness of these screws by hand. If these screws are present and secure, you may continue use of the system. If any of these screws are missing or can easily be turned by hand, follow the precautions below before you continue use with the monitor(s). 1. Position the monitor suspension in the most frequently used position and limit further movement as much as possible. 2. Clearly inform (e.g. through signage and verbal instructions) the users and other auxiliary personnel who may come in contact with the system to not move the monitor suspension once in position. 3. Contact your GE Healthcare representative to inform them of any loose or missing screws. For questions or concerns regarding this notification, please contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.

Device

Device Recall GE Healthcare Precision RXi Digital system
  • Model / Serial
    Mfg Lot or Serial # 00000003510MC5 00000004082MC4 00000001524MC8 00000004565MC8 00000004022MC0 00000001590MC9 00000002033MC9 00000004021MC2 00000001528MC9 00000001975MC2 00000002235MC0 00000003739MC0 00000001147MC8 00000001280MC7 00000000953MC0 00000001645MC1 00000001319MC3 00000002255MC8 00000004585MC6 00000001473MC8 00000001292MC2 00000004110MC3 00000001354MC0 00000001744MC2 00000002104MC8 00000001020MC7 00000001093MC4 00000001429MC0 00000001453MC0 00000001407MC6 00000001388MC8 00000001374MC8 00000001296MC3 00000001652MC7 00000001381MC3 00000004024MC6 00000004160MC8 00000001380MC5 00000001969MC5 00000001100MC7 00000001170MC0 00000004108MC7 00000003844MC8 00000001288MC0 00000004702MC7 00000004703MC5 00000001394MC6 00000001527MC1 00000001428MC2 00000004597MC1 00000004027MC9 00000003966MC9
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide Distribution including GU and DC., and to the countries of : Australia, Bulgaria, Canada, Chile, Dominican Republic, Germany, Ireland, Italy, Kuwait, Lebanon, Portugal, Romania, Russia, Saudi Arabia, Slovakia, Spain, Taiwan,Turkey, United Kingdom, Venezuela and Yemen.
  • Product Description
    GE Healthcare Precision RXi Digital system
  • 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