Events

Recall of Device Recall GE Healthcare RFX

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
    75851
  • Event Risk Class
    Class 2
  • Event Number
    Z-0915-2017
  • Event Initiated Date
    2016-11-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-09-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151918
  • 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
    Table, radiographic, tilting - Product Code IXR
  • Reason
    Ge healthcare is conducting a recall due to the potential fall of aged crt monitors - prestige 2, prestilix, prestige vh, prestige si, rfx/sfx, legacy, precision 500d, advantx and innova 2000 systems.
  • Action
    Consignees were sent on 11/21/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# FMI 10913 dated November 21, 2016. The letter was addressed to Director of Radiology, Risk Manager/Hospital Administrator, and Director of Biomedical Engineering. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. If you have any 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 RFX
  • Model / Serial
    Mfg. Lot or Serial # System ID Not Available 818963RM4 00000026176YY8 213266SFX Not Available 209384MMRF 00000047956YY8 INSIGHTXR010 Not Available 818891VA1 Not Available 818891VA2 Not Available 2025761X46 Not Available 2025761X40 Not Available 813633RFX Not Available 813971RF6 Not Available 708259NWRF7 00000034249YY3 913596PR4 00000023702YY4 606327ADV Not Available 504867LRF2 Not Available 318388RF3 00000023806YY3 617735B6 00000022210YY9 313576RM1663 00000022218YY2 313576RM3622 Not Available 313576RM3645 Not Available 218726SMRF2 Not Available 601865RF1 Not Available 601865RF2 Not Available 601376OP3 Not Available 919681DB3 Not Available 919250WM9 00000026194YY1 706791D7 Not Available 914964SJRF 00000071239YY8 405271PRF4 00000022200YY0 215576RF18 00000128622MO8 615871SRF1 Not Available 817965HADV Not Available 713364W03 Not Available 206244RM2 00000022207YY5 EG1055VA01 00000022140YY8 SK1005RX05 00000023856YY8 AE1020RX01
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US: AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT,NC, NE NH, NJ, NM, NY, NV, OH, OK, PA, RI, SC, SD, TN, TX,, VA, WA, WO, WY, WV. OUS: Algeria Armenia Australia Austria Brazil Canada Chile China Denmark Egypt France Germany Guatemala Honduras Hong Kong Hungary Iceland India Ireland Italy Japan Korea Libya Mexico Netherlands Netherlands Peru Poland Portugal Russia Saudi Arabia Serbia Sierra Leone Slovakia Spain Taiwan Thailand Turkey United Arab Emirates United Kingdom Venezuela Vietnam
  • Product Description
    RFX
  • 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