Recall of Device Recall Celex/GE Precision MPi

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by NRT - Nordisk Rontgen Teknik A/S.

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
    52173
  • Event Risk Class
    Class 2
  • Event Number
    Z-1658-2009
  • Event Initiated Date
    2009-05-01
  • Event Date Posted
    2009-09-29
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2009-10-20
  • Event Source
    USFDA
  • Event Source URL
  • 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
    Image-Intensified Fluoroscopic X-Ray System - Product Code JAA
  • Reason
    The ge precision mpi is in violation with 21 cfr part 1020.32 requiring a signal audible to the fluoroscopist to sound for each passage of 5 minutes of fluoroscopic irradiation time during an examination or procedure.
  • Action
    An Advisory Notice concerning GE Precision MPi, dated May 1, 2009, was issued to Healthcare Professionals. The notice discussed the problem, risk, recommended immediate action, future actio, and affected system and serial numbers. A GE Field Service Representative will visit each affected U.S. customer site and introduce a speaker connected to the generator touch screen (to which the audible tone is delivered) in the operator's room, to be placed on the wall in the x-ray room. For further information, customers were to contact their local GE field engineer.

Device

  • Model / Serial
    Serial Numbers: 507003, 507004, 507005, 510004, 510009, 510010, 513001, 513003, 513007, 518001, 518002, 518004, 518005, 518006, 518011, 518013, 518014, 518015, 518017, 518018, 518020, 522001, 522002, 522003, 522004, 522005, 522006, 522008, 522009, 522012, 522014, 522015, 522016, 522018, 522019, 536001, 536002, 536003, 536006 and 536007.
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution, including CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OR, PA, TN, VT, WA, WI.
  • Product Description
    Celex/GE Precision MPi, REF no.: 02980000 || Is an all-digital multipurpose tilt-C X-ray system, intended for a multitude of diagnostic procedures, including: R&F;, radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies.
  • Manufacturer

Manufacturer

  • Manufacturer Address
    NRT - Nordisk Rontgen Teknik A/S, Birkegaardsvej 16, Hasselager Denmark
  • Source
    USFDA