Events

Recall of Device Recall Revolution XR/d

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems, 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
    53157
  • Event Risk Class
    Class 2
  • Event Number
    Z-0002-2009
  • Event Initiated Date
    2008-02-14
  • Event Date Posted
    2009-09-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-01-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84800
  • 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
    Tomographic X-Ray System - Product Code KPR
  • Reason
    Ge healthcare has recently become aware of a potential risk of observing a blank image after exposure on revolution xr/d systems equipped with hp 8200 pc user consoles that may impact patient safety. it was reported that images acquired with off-center collimation for extremities with the position selected as digits to front or digits to back are displayed as blank. investigation into th.
  • Action
    Consignees were sent a GE Healthcare "Product Safety Notification" letter dated March 7, 2008. The letter was addressed to Hospital Administrators, Mangers of Radiology and Radiologists. The letter listed the Safety Issue, Affected Product, Safety Instructions, Corrective Action and Contact Information.

Device

Device Recall Revolution XR/d
  • Model / Serial
    SERIAL 00001002491WK7 00000100291WK7 00000999999WK6 00001001816WK6 00001001824WK0 00000995364WK7 00000996497WK4 00000068396WG1 00000995361WK3 00000996218WK4 00000001239M33 00001000600WK5 00000996216WK8 00000001247M36 00000998382WK6 00001001814WK1 00000995360WK5 00001004793WK4 00000998805WK6 00000994499WK2 00001006377WK4 00000997607WK7 00000999065WK6 00001004294WK3 00001005696WK8 00000998799WK1 00000997599WK6 00000992542WK1 00000069597WG3 00001004299WK2 00001002488WK3 00001002487WK5 00000998941WK9 00000998939WK3 00000995356WK3 00000993793WK9 00001000954WK6 00001001827WK3 00000998388WK3 00001005678WK6 00001003046WK8 00001001837WK2 00000035324HL3 00000997608WK5 00001002486WK7 00000998945WK0 00000995366WK2 00000998391WK7 00000994494WK3 00000993374WK8 00000037897HL6 00000001238M35 00000999698WK4 00001003557WK4 00000998383WK4 00001002483WK4 00000999993WK9 00001000956WK1 00000998386WK7 00000997605WK1 00000997602WK8 00000998938WK5 00001001810WK9 00000996491WK7 00001001085WK8 00000035064HL5 00001002490WK9 00001000950WK4 00000996495WK8 00000996791WK0 00000996500WK5 00000996209WK3 00000994488WK5 00000034881HL3 00001000951WK2 00001001799WK4 00001003566WK5 00001003045WK0 0000USU4400NXJ 00000997069WK0 00001002489WK1 00000996498WK2 00001001811WK7 00001000958WK7 00000998392WK5 00000996792WK8 00001004296WK8 00000998944WK3 00001001800WK0 00001003561WK6 00000995353WK0 00001001818WK2 00001005004WK5 00000998937WK7 00000996499WK0 00001002482WK6 00000996212WK7 00001003553WK3 00001000000WK8 00000995349WK8 00000996684WK7 00000998156WK4 00001004304WK0 00000036505HL6 00000994505WK6 00001000952WK0 00000997182WK1 00000998804WK9 00000995368WK8 00000995357WK1 00000994491WK9 00001001807WK5 00000999998WK8 00001005694WK3 00000993794WK7 00001000955WK3 00000064580WG4 00001001822WK4 00001003554WK1 00000998942WK7 00000996789WK4 00001004791WK8 00000996227WK5 00000001173M34 00001000957WK9 00000081110MA9 00001004139WK0 00001004298WK4, and 0000000069365W.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- AL, AZ, CA, CO, FL, GA, HI, IL , IN, KY, LA, MD, MA, MI,MN,MS, MO, MT, NE, NH, NJ, NM, NY, NC, OH, OK OR, PA, SC, TN, TX, VA, WA, and WV.
  • Product Description
    Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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