Events

Recall of Device Recall COMPAX 40E Xray Systems

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
    52720
  • Event Risk Class
    Class 2
  • Event Number
    Z-0457-2010
  • Event Initiated Date
    2009-07-30
  • Event Date Posted
    2009-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=83813
  • 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
    Non-Tilting Powered Radiographic Table - Product Code IZZ
  • Reason
    Ge healthcare has recently become aware that table lock safety features, which are provided with compax 40e x-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient safety.
  • Action
    Consignees in US and Canada were sent on July 31, 2009 a GE Healthcare "Urgent Medical device Correction" letter dated July 30, 2009. The letter was addressed to Hospital Administrators/ Risk mangers; Radiology Department Mangers; Radiologists. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product correction, and Contact Information. The letter instructs customers that the table manual mechanical lock is provided with the system and should be engaged when loading or unloading patients to ensure the tabletop is stabilized and not moving. For the rest of the world, the customer letter was dated October 22, 2009 and was mailed October 30, 2009.

Device

Device Recall COMPAX 40E Xray Systems
  • Model / Serial
    SYSTEM SERIAL  00000059301ES2  00000059308ES7  00000059350ES9  00000059655ES1  00000059657ES7  00000059682ES5  00000059699ES9  00000059701ES3  00000061281ES2  00000061285ES3  00000061288ES7  00000061292ES9  00000061312ES5  00000063191ES1  00000063197ES8  00000063200ES0  00000063201ES8  00000063202ES6  00000063218ES2  00000064023ES5  00000064031ES8  00000064045ES8  00000064050ES8  00000065211ES5  00000065212ES3  00000066155ES3  00000068507MA3  00000068516MA4  00000068518MA0  00000069848MA0  00000071567MA2  00000071568MA0  00000071569MA8  00000076137MA9  00000078106MA2  00000078109MA6  00000078110MA4  00000079274MA7  00000062896ES6  00000062904ES8  00000062905ES5  00000062907ES1  00000062908ES9  00000064086ES2  00000064683ES6  00000065711ES4  00000066419MA3  00000068887MA9  00000068890MA3  00000068894MA5  00000068899MA4  00000069099MA0  00000069872MA0  00000069881MA1  00000069905MA8  00000069906MA6 907276H02A 00000061271ES3 907580EF2 00000059667ES6 907458CAN 00000065215ES6 907458MDA1 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 11945465XR1 00000061756ES3 B5374201 00000066164ES5 A5152946 00000063277ES8  00000069088MA3  00000069090MA9  00000066026ES6 G5119102 00000076218MA7 B5422501 00000066044ES9 A122087502 00000080306MA4 B5127224 00000064794ES1 A5109205 00000063238ES0 B5810515 00000063253ES9 A5304501 00000068956MA2 B5127415  A5183636 00000068267MA4 A5119115  A5604201 00000067978MA7 A5314607 00000071411MA3 IL1190RX01 00000073494MA7 IL1189RX01 00000073495MA4  00000066166ES0 0828070093  0828070084  828070083 00000063230ES7 828070082 00000063234ES9  00000063198ES6 H2077RAD08 00000063258ES8 H2077RAD09 00000064053ES2 H2197RAD01 00000063233ES1 HC6582XR14 00000079196MA2  00000068270MA8  00000066847MA5 HC1680XR01 00000068266MA6 PF1003RX03 00000065022ES6 M4478120 00000079199MA6 M1226605 00000071408MA9 M9258803 00000071409MA7 A1433801 00000075904MA3 M4174904 00000073491MA3 B8322601 00000063275ES2 C60183004 00000073492MA1 M5158515 00000064957ES4 A1082409 00000065310ES5 M6021212 00000066023ES3 M4498514 00000065042ES4 M1102011  C1661401  M2806003 00000076219MA5 M5460626 00000063244ES8 M5460628 00000063243ES0 M9490516 00000063236ES4 M4198159 00000063252ES1 A1588512  M4496210 00000063245ES5 A6038308  B1121607 00000069092MA5  00000066848MA3 B2485201 00000065309ES7 GOLD000968  GOLD001023  GOLD000969  EG1112RX01 00000070203MA5 EG1112RX02 00000070206MA8 EG1112RX03 00000070207MA6 EG1112RX08 00000070204MA3 EG1112RX08 00000070205MA0 EG3000RX01   00000062878ES4 082407220007  082407160038  082407160039  82407220007 00000066163ES7 82407160038 00000068268MA2 82407160039 00000068269MA0 905842RAD 00000064076ES3 416340ADVTX 00000059658ES5 819855COMPAX 00000069850MA6 418659COMPAX 00000063221ES6 25980  AH5290XR02  0910072061  910072061 00000066165ES2 0910072054  910072055 00000063271ES1 910072053 00000063272ES9 910072049 00000063269ES5, and  910072054 00000063273ES7.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- USA, including states of AL, AK, AZ, AR, CA, CO, CT, DC,FL, GA, HI, ID, IL , IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NH,NJ, NM, NY, NC, OH, OK OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WY and countries of UNITED KINGDOM, THAILAND, TAIWAN, SWITZERLAND, SPAIN, SAUDI ARABIA, PUERTO RICO, PORTUGAL NEW CALEDONIA, MARTINIQUE, KOREA, JAPAN, JAMAICA, ITALY, ISRAEL, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, EGYPT, DOMINICAN, CHINA, CANDA, BRAZIL AUSTRIA, and AUSTRALIA.
  • Product Description
    GE Medical Systems, COMPAX 40E X-ray Systems, Models; 2208203, 2208205, 2244282, 2244284, 2225863, 2225864 , 2225865, 2225870, 2225881, and 2225882. || Intended to be used for general purpose radiography and tomography.
  • 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