Events

Recall of Device Recall GE PET/CT System

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

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
    73248
  • Event Risk Class
    Class 2
  • Event Number
    Z-1053-2016
  • Event Initiated Date
    2016-02-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143783
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Ge healthcare has updated the service manuals for a number of ct and pet ct scanners to update an incorrect torque value.
  • Action
    GE Healthcare sent an Urgent Medical Device Correction letter " GEHC Ref# 25467-ABT or 25467" dated February 12, 2016, to all affected consignees . The letter was addressed to Hospital Administrators / Risk Managers, Managers of Radiology/Cardiology, & Radiologist/Cardiologist. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. Consignees were instructed to ensure that the organization that service their equipment uses the latest version of the Service Manual to maintain the safe and proper performance of their medical device. For questions call in the United States: 1-800-437-1171 or your local GE Healthcare Service Representative. For questions regarding this recall call 262-513-4122.

Device

Device Recall GE PET/CT System
  • Model / Serial
    Mfg Lot or Serial # System ID 00000006841PT1 PET368725CN8 00000004411PT5 4512-1 00000004411PT5 4512-1 00000006841PT1 PET368725CN8 00000005376PT9 PET357769CN9 00000005670PT5 082426140014 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006610PT0 082445020003 00000006119PT2 082445030003 00000005815PT6 082445050003 00000006146PT5 082445090002 00000005808PT1 082445100008 00000006177PT0 082445100009 00000006175PT4 082445130004 00000005670PT5 082426140014 00000005808PT1 082445100008 00000006500PT3 082445160007 00000006242PT2 082445190002 00000006200PT0 082445250002 00000005251PT4 H4858964 00000005121PT9 M4143813 00000005352PT0 M4144860 00000005323PT1 X105967801 00000006194PT5 HU1167PT01 00000006762PT9 0004168403 00000006762PT9 0004168403 00000005809PT9 IE1005PT01 00000004588PT0 IL1062NM18 00000006120PT0 A5107746 UNK51012720002 A5107746 UNK51012720001 A5215931 00000006003PT8 A5333025 00000004619PT3 A99263301 00000006292PT7 YD0024 00000006293PT5 YD0025 00000006039PT2 YE0001 00000006273PT7 YE0002 00000006272PT9 YE0003 00000006345PT3 YE0004 00000006346PT1 YE0005 00000006808PT0 YE0006 00000006488PT1 YE0007 00000006403PT0 YE0008 00000006368PT5 YE0011 00000006274PT5 YE0077 00000005920PT4 YE0101 00000006141PT6 YE0102 00000006076PT4 YE0103 00000006404PT8 YE0104 00000006496PT4 YE0105 00000006405PT5 YE0106 00000006453PT5 YE0107 00000006636PT5 YE0108 00000006331PT3 YE0110 00000006347PT9 YE0111 00000006454PT3 YE0112 00000006115PT0 YE0201 00000006407PT1 YE0202 00000006611PT8 YE0203 00000006245PT5 YE0205 00000006810PT6 YE0210 00000006843PT7 YE0211 00000005813PT1 YE0214 00000006367PT7 YE0109 00000006304PT0 YE0204 00000005813PT1 YE0214 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004967PT6 0850450042 00000004463PT6 0850450055 00000005495PT7 0850450056X1 00000005342PT1 0850450057 00000005342PT1 0850450057 00000005878PT4 0850450058 00000006176PT2 0850450059 00000006176PT2 0850450059 00000005785PT1 0834450001 00000005785PT1 0834450001 00000005719PT0 2535997DST 00000005719PT0 2535997DST 00000006486PT5 2546945DST 00000006148PT1 FE816135 UNK51012720004 FE816135 00000004732PT4 FEG81300 00000006302PT4 NP739714 UNK51012720000 Not Available 00000006201PT8 C001PE03 00000006201PT8 C001PE03 00000006294PT3 259130PE01 00000006294PT3 259130PE01 00000005184PT7 0853450020 00000004676PT3 0853450021 00000005784PT4 0853450023 00000005880PT0 0853450026 00000006244PT8 0853450038 00000006244PT8 0853450038 00000006501PT1 0853450062 00000004624PT3 06008PET01 00000005169PT8 01293DST01 UNK51012720003 10495DST01 00000005892PT5 561883DST 00000006457PT6 388559737PETMET
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US including all states in including PR except ND, VT & WY. Foreign Distribution: ALBANIA, ARGENTINA, AUSTRALIA, AUSTRIA, BELGIUM, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, BURKINA FASO, CAMERON, CANADA, CHILE, CHINA, COLOMBIA, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, GUADELOUPE,HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRA N, IRAQ, IRELAND, ISRAEL, ITALY, JAPAN, JORDAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PERU, PHILIPPINES, POLAND, PORTUGAL, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA .
  • Product Description
    LightSpeed QX/I (4-slice MDAS) || LightSpeed 4.0 CT Scanner System - The LightSpeed 4.0 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. PET Discovery ST system - The GE Discovery ST system is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery ST is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery ST system can also be used as a stand-alone head and whole body multi-slice computed tomography (CT) diagnostic imaging system. LightSpeed Pro16 - The Lightspeed 5.0 CT Scanner System is indicated for head and whole body X-ray computed tomography applications. 16 Slice BGO PET/CT System - The GE Discovery XR and XA Systems are intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery XR and XA are to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. These devices can also assist in radiotherapy planning. The Discovery XR and XA can also be used as stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging systems. 6 Slice BGO PET/CT System - The GE Discovery LS System is intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging and localization of emission activity in patient anatomy by means of integrated PET and CT images. The Discovery LS is to be used by trained health care professionals for imaging the distribution of radiopharmaceuticals in the body for the assessment of metabolic (molecular) and physiologic functions. This can assist in the evaluation, diagnosis, staging, restaging, and follow up of lesions, disease and organ function such as (but not limited to) cancer, cardiovascular disease, and brain dysfunction. This device can also assist in radiotherapy planning. The Discovery LS can also be used as a stand-alone head and whole body multislice computed tomography (CT) diagnostic imaging system.
  • Manufacturer
    GE Medical Systems, LLC

Manufacturer

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