Events

Recall of Device Recall GE Healthcare Lunar Lunar DPX NT; DPX MD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by GE Medical Systems Ultrasound & Primary Care Diagnostics, LL.

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
    79710
  • Event Risk Class
    Class 2
  • Event Number
    Z-1394-2018
  • Event Initiated Date
    2018-03-16
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=163128
  • 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
    Densitometer, bone - Product Code KGI
  • Reason
    Under certain conditions, when using dicom worklist along with dicom mpps, a report for a bone density exam may be sent to pacs with the incorrect patient information in the dicom header. the correct patient information will be listed on the dicom report image; however, the report may appear under a different patients name in the pacs.
  • Action
    The firm initiated their recall by letter on March 16, 2018. The notice stated: "Under certain conditions, when using DICOM Worklist along with DICOM MPPS, a report for a bone density exam may be sent to PACS with the incorrect patient information in the DICOM header. The correct patient information will be listed on the DICOM report image; however, the report may appear under a different patients name in the PACS. There have been no injuries reported as a result of this issue. You can continue using your system by disabling the DICOM MPPS feature as follows: 1. In enCORE, select Tools | Connectivity Options. 2. Select DICOM tab. 3. Press Configure Connections in DICOM Worklist section. 4. In the MPPS SCP Settings, clear the AE Title and the TCP/IP Address fields 5. Press OK to all. A GE Healthcare representative will contact you to arrange for the correction." For further questions, please call (608) 826-7492

Device

Device Recall GE Healthcare Lunar Lunar DPX NT; DPX MD
  • Model / Serial
    a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Egypt, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Malaysia, Malta, Mexico, Morocco, Norway, Poland, Portugal , Romania, Russia, Saudi Arabia, Spain, Switzerland, Taiwan, Tunisia, Turkey, United Arab, United Kingdom and Venezuela.
  • Product Description
    GE Healthcare Lunar: || a) DPX NT, Model Numbers: LU8230, LU40338, LU42357, LU42369 || b) DPX MD+, Model Numbers: LU8230, LU40338, LU40352 || Provides an estimate of BMD (Bone Marrow Density) at the lumbar spine and proximal femur regions. This BMD value can then be compared to a reference population at the sole discretion of the physician.
  • Manufacturer
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL

Manufacturer

GE Medical Systems Ultrasound & Primary Care Diagnostics, LL
  • Manufacturer Address
    GE Medical Systems Ultrasound & Primary Care Diagnostics, LL, 3030 Ohmeda Dr, Madison WI 53718-6704
  • Manufacturer Parent Company (2017)
    General Electric Company
  • Source
    USFDA