Events

Recall of GE OEC 9900 Elite Carm, Fluoroscopic system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE OEC Medical Systems, Inc.

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
    36403
  • Event Risk Class
    Class 2
  • Event Number
    Z-0042-2007
  • Event Date Posted
    2006-10-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48599
  • 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
    Fluoroscopic Xray - Product Code JAA
  • Reason
    X-ray system may lose or mix images and/or lose patient data.
  • Action
    Consignees will be notified by letter beginning 10/21/2006.

Device

GE OEC 9900 Elite Carm, Fluoroscopic system
  • Model / Serial
    Serial numbers: E2-0001 thru E2-0065, E2-0066-CH, E2-0067 thru E2-0152, E2-0156 thru E2-0159, E2-0166, E2-7001-MH thru E2-7033-MH, E2-7034-CMH, E2-7035-MH thru E2-7056-MH, E9-0001, E9-0003, E9-0005 thru E9-0013, E9-0015 thru E9-0031, E9-0033, E9-0034, E9-0038, E9-0039, E9-0043 thru E9-0082, E9-00084, E9-0086, E9-0087, E9-0096, E9-0097, E9-0104, E9-0105, E9-0106, E9-0107, ES-0001, ES-0004, ES-0005, ES-0006, ES-0007-C, ES-0008, ES-0009, ES-0010, ES-0011-H, ES-0012-H, ES-0017, ES-0019, ES-0022-CH, ES-0029-CH, ES-0030, ES-0036-CH, ES-0037, ES-0038, ES-0039, ES-0045-H, ES-0046-CH, ES-0047, ES-0048, ES-0049-H, ES-0050 thru ES-0059, ES-0060-H, ES-0061, ES-0062-H, ES-0063-H, ES-0064, ES-0065, ES-0066-CH, ES-0067 thru ES-0080, ES-0091-H, ES-0092-CH, ES-0093, ES-0094, ES-0095, ES-0096, ES-0099-CH, ES-0100-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0106, ES-0107, ES-7001-CMH, ES-7002-MH, ES-7003-MH, ES-7004-CMH, ES-7005-MH, ES-7006-CMH thru ES-7013-CMH, ES-7014-MH thru ES-7018-MH, ES-7019-CMH, ES-7020-CMH, ES-7022-CMH, ES-7023-CMH, ES-7024-CMH, ES-7025-CMH, ES-7026-MH, ES-7027-MH.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, including VA facilities in FL, NC, WA and military accounts in GA and WA. Foreign distribution to Australia, Belgium, Canada, Finland, France, Germany, Italy, Netherlands, New Zealand, Singapore, Spain, Sweden, Switzerland, UK.
  • Product Description
    OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210, GE OEC Medical Systems, Inc.
  • Manufacturer
    GE OEC Medical Systems, Inc

Manufacturer

GE OEC Medical Systems, Inc
  • Manufacturer Address
    GE OEC Medical Systems, Inc, 384 Wright Brothers Dr, Salt Lake City UT 84116-2862
  • Source
    USFDA