Events

Recall of Device Recall GE Precision MPi

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

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
    49471
  • Event Risk Class
    Class 2
  • Event Number
    Z-2142-2008
  • Event Initiated Date
    2008-05-01
  • Event Date Posted
    2008-09-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73504
  • 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
    Multi-purpose X-ray system - Product Code JAA
  • Reason
    The precision mpi collimator did not contain a label identifying the device as being certified to comply with applicable requirements of the x-ray performance standard.
  • Action
    GE Field Engineers visited affected customers to make the correction.

Device

Device Recall GE Precision MPi
  • Model / Serial
    serial numbers: 507001, 507002, 507003, 507004, 507005, 507006, 507007, 507008, 510001, 510002, 510003, 510004, 510005, 510006, 510007, 510008, 510009, 510010, 513001, 513002, 513004, 513005, 513006, 513007, 513008, 513009, 513010, 513011, 518002, 518003, 518004, 518005, 518006, 518007, 518008, 518009, 518010, 518011, 518012, 518013, 518014, 518015, 518016, 518017, 518018, 518019, 518020, 522001, 522002, 522003, 522004, 522005, 522006, and 522008.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Within the US to include: CA, CO, FL, IN, MA, MN, NV, NY, OR, PA, TN, VT, WA, and WI. OUS to include: CANADA, GERMANY, ITALY, POLAND, SAUDI ARABIA, SLOVAKIA, SPAIN, TURKEY, and UNITED KINGDOM,
  • Product Description
    GE Precision MPi, model 5126893. GE Medical Systems - Americas, Milwaukee, USA || The product is used to generate radiographic and fluoroscopic images of human anatomy, perform interventional procedures, perform vascular and non-vascular procedures, and other specialized applications, including angiographic studies.
  • Manufacturer
    GE Healthcare

Manufacturer

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