Events

Recall of Device Recall GE Healthcare SFX

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-0916-2017
  • 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=151919
  • 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 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 SFX
  • Model / Serial
    Mfg. Lot or Serial # System ID 00000119847MO2 205345RF2 Not Available 501239AMR3 00000063563YY1 602588OP1 Not Available 805326KM3 00000031477YY3 619725RM2 00000031386YY6 619725RM6 Not Available 707263LXR2 Not Available 209578AVTX 00000034272YY5 805497RM7 00000031317YY1 916555RF1 00000039665YY5 415750S9 00000026124YY8 415565DFL2 00000063453YY5 714985R3 Not Available 813932SPEC 00000023723YY0 229312DRS Not Available 404589GSF 00000026193YY3 404791D4A 00000063484YY0 319652ADVRF Not Available 618549CMRF1 00000023674YY5 317662RM4 Not Available 317662RM3 Not Available 812232ARM2 00000023719YY8 502746RF Not Available 318948DRS Not Available 301891RM1 Not Available 410337RF 00000023681YY0 313493ADV 00000023705YY7 517334ADV 00000022193YY7 612243RF 00000031310YY6 816276BRF1 Not Available 704342NR5 Not Available 704765RF1 00000022177YY0 201858RM3 00000022171YY3 505887GRF1 00000022159YY8 505392RF2 Not Available 516579R2 00000052108YY8 718739RF 00000023699YY2 212844RM3 00000031337YY9 405323CRF 00000039657YY2 215831SP Not Available 803522B2 00000052115YY3 803899RF1 00000023744YY6 423926RF Not Available 409883BRF 00000023676YY0 817735FP2 00000026181YY8 703783ARF4 Not Available 703459RF1 00000026111YY5 414529RF1 Not Available 414D1183 00000023843YY6 304348MX8 00000022190YY3 304647GX1 00000022132YY5 00658FLU01
  • 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
    SFX
  • 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