Events

Recall of PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: || ¿ Siemens Models: Biograph PET/CT || ¿ CTI Models: Reveal PET/CT

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
    30802
  • Event Risk Class
    Class 2
  • Event Number
    Z-0547-05
  • Event Initiated Date
    2004-05-27
  • Event Date Posted
    2005-02-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=36628
  • 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
    Misalignment of ct and pet scans from performing additional ct scans may produce an incorrect fused data set. in performing additional ct scans, the original pet and ct scans may become misaligned and produce an incorrect fused data set.
  • Action
    Written notification was sent via letter on May 27, 2004 to the end users to alert the consignees of the problem. The corrective software was mailed on December 17, 2004.

Device

PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography)...
  • Model / Serial
    0054081001, 0054081002, 0054081003, 0054081004, 0054081006, 0054081007, 0054081008, 0054081009, 0054081010, 0054081011, 0054081012, 0054081013, 0054081014, 0054081015, 0054081016, 0054081017, 0054081018, 0054081020, 0054081021, 0054081022, 0054081023, 0054081024, 0054081025, 0067331002, 0067331003, 0067331004, 0067331005, 0067331006, 0067331007, 0067331008, 0067331009, 0067331010, 0067331011, 0067331012, 0067331013, 0067331014, 0067331015, 0067331016, 0067331017, 0067331018, 0067331019, 0067331020, 0067331021, 0067331022, 0067331023, 0067331024, 0067331025, 0067331026, 0067331027, 0067331029, 0067331030, 0067331031, 0067331032, 0067331033, 0067331034, 0067331035, 0067331036, 0067331037, 0067331038, 0067331039, 0067331040, 0067331041, 0067331042, 0067331043, 0067331044, 0067331045, 0067331046, 0067331047, 0067331048, 0067331049, 0067331050, 0067331051, 096-001002, 096-001004, 096-001005, 096-001006, 096-001007,  096-001008, 096-001009, 096-001011, 096-001012, 096-001013, 096-001014, 096-001015,  096-001016, 096-001017, 096-011002, 096-011003, 096-011005, 096-011006, 096-011007,  096-011008, 096-011009, 096-011010, 096-011011, 096-011012, 096-011013, 096-011014,  096-011015, 096-011016, 096-011017, 096-011018, 096-011019, 096-011020, 214-001002,  214-001003, 214-001004, 214-001005, 214-001006, 214-001007, 214-001008, 214-001016,  214-01001A, 214-011001, 214-011002, 214-011003, 214-011004, 214-011005, 214-011006,  214-011007, 214-011008, 214-011009, 214-011010, 214-011011, 214-011012, 214-011013,  214-011014, 214-011015, 214-011017, 214-011018, 214-011019, 214-011020, 214-011021,  214-011022, 214-011023, 214-011024, 214-011025, 214-011026, 214-011027, 214-011028,  214-011029, 214-011030, 214-011031, 214-011032, 214-011033, 214-011034, 214-011035,  214-011036, 214-011037, 214-011038, 214-011039, 214-011040, 214-011041, 214-011042,  216-001001, 216-001006, 216-001009, 216-001011, 216-001013, 216-001014, 216-001015,  216-001016, 216-001017, 216-001018, 216-001019, 216-001020, 216-001021, 216-001022,  216-001023, 216-001024, 216-001026, 216-001027, 0064871002, 0064871003, 0064871004, 0064871005, 0064871006, 0064871007, 0064871008, 0064871009, 0064871010, 0064871011, 0064871012, 0064871013, 0064871014, 0064871015, 0064871016, 0064871017, 0064871018, 0064871019, 0064871020, 0069391014, 0071301002, 0071301003, 0071301004, 0071301005, 0071301006, 0071301007, 0071301008, 0071301009, 0071301010, 0067331011, 0071301012, 0071301013, 0071301015, 0071301016, 0071301017, 0071301018, 0071301019, 0071301020, 0071301021, 0071301022, 0071301024
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Germany, Spain, Italy, Korea and Canada
  • Product Description
    PET/CT Software Versions MSV 1.0 and 1.1 used in the following PET (Positron Emission Tomography) and X-Ray Computed Tomography (CT) systems: || ¿ Siemens Models: Biograph PET/CT || ¿ CTI Models: Reveal PET/CT
  • Manufacturer
    CTI PET Systems Inc

Manufacturer

CTI PET Systems Inc
  • Manufacturer Address
    CTI PET Systems Inc, 810 Innovation Dr, Knoxville TN 37932-2562
  • Source
    USFDA