Events

Recall of mobile system PET scanner

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by CTI PET 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
    31770
  • Event Risk Class
    Class 2
  • Event Number
    Z-0819-05
  • Event Initiated Date
    2005-04-05
  • Event Date Posted
    2005-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-09-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38469
  • 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
    System, Tomography, Computed, Emission - Product Code KPS
  • Reason
    Failure to properly secure the mobile bed supports during transit could cause the support screws on the patient handling system to become loose and possibly break due to increased vibration during transit.
  • Action
    Written notification via certified US Mail was sent out beginning 04/05/2005 to distributors and end users (with whom CTI had a service contract) to advise them of the problem.

Device

mobile system PET scanner
  • Model / Serial
    Model Number: 3600079-00 Serial numbers: 0001013, 0001014  Model Number: 3600088-00 Serial numbers: 0001010, 0001016, 0001017, 0001019, 0001021, 0001023, 0001027, 0001029, 0001030, 0001031, 0001038, 0001041, 0001048, 0001051, 0001053, 0001054  Model Number: 3600097-00 Serial numbers: 0101004, 0101019, 0101025, 0101033, 0201041, 0201049, 0201053, 0201063  Model Number: 3600211-00 Serial numbers: 0101007, 0101016, 0101018, 0201023, 0201048, 0201050, 0201058, 0201064, 0201072, 0301082,   Marketed under Siemens Model Number: 3600211-00 0101002, 0101004, 0101015, 0101014, 0101020, 0101021, 0201029, 0201028, 0201035, 0201062, 0201059, 0201063, 0201070, 0301110  Model Number: 3600079-00 Serial numbers: 0001010, 0001011, 0001018  Model Number: 3600085-00 Serial numbers: 0001001, 0001002  Model Number: 3600088-00 Serial numbers: 0001003, 0001006, 0001020, 0001035, 0001036, 0001043, 0001045, 0001044, 0001056, 0001062  Model Number: 3600097-00 Serial numbers: 0101016, 0101018, 0101030, 0201036, 0201040, 0201060  Model Number: 3600211-00 Serial numbers: 0201033, 0201034, 0201067, 0301108  Model Number: 3600099-00 Serial numbers: 0301024  Model Number: 3600088-00 Serial numbers: 001058  Model Number: 3600097-00 Serial numbers: 0101034, 0201038, 0201061
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Canada, the Netherlands, Ireland & Denmark
  • Product Description
    ECAT PET Scanners (mobile systems), distributed by Siemens Medical Solutions || ECAT PET Scanners (mobile systems), and Reveal XL (mobile systems), distributed by CTI Molecular Imagining, Inc. || Sceptre and Sceptre XL (mobile systems) distributed by Hitachi Medical Systems America
  • Manufacturer
    CTI PET Systems Inc

Manufacturer

CTI PET Systems Inc
  • Manufacturer Address
    CTI PET Systems Inc, 810 Innovation Drive, Knoxville TN 37932-2571
  • Source
    USFDA