• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall GE PET Discovery 610, PET Discovery 710

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall GE PET Discovery 610, PET Discovery 710 see related information
Date Posted October 17, 2013
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0024-2014
Recall Event ID 65958
510(K)Number K081496 
Product Classification System, tomography, computed, emission - Product Code KPS
Product GE PET Discovery 610, PET Discovery 710.

Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging.
Code Information MfgLotorSerial#
00000428413CN9
00000429077CN1
00000429247CN0
00000430152CN9
00000430656CN9
00000430999CN3
00000431369CN8
00000429701CN6
00000430064CN6
00000431187CN4
00000429354CN4
00000431447CN2
00000293950HM2
00000429821CN2
00000429946CN7
00000430001CN8
00000293950HM2
00000430632CN0
Shipped
Shipped
Shipped
00000429572CN1
00000428755CN3
00000428755CN3
00000428868CN4
00000293949HM4
00000428536CN7
00000429820CN4

Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
262-513-4122
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID
FDA Determined
Cause 2
Software design (manufacturing process)
Action Consignees were sent a GE Healthcare "Urgent Medical Device Correction" letter dated March 26, 2013. The letter was addressed to Director of Radiology, Emergency Medicine Physicians and Radiologic Technologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information.
Quantity in Commerce 28 (4 US & 24OUS)
Distribution Worldwide Distribution-USA (nationwide) including the states of AZ, CA, CO, FL, GA, IL, IA, IS, LA, MA, MO, NH, NM, NY, OH, OK PA, SC, TX, UT, VA, WA, and WI, and the countries of UNITED KINGDOM, DENMARK, CHILE, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CZECH REPUBLIC, ECUADOR, EGYPT, ETHIOPIA, FINLAND, FRANCE, FRANCE GUIANA, GERMANY, GUADELOUPE, GUATEMALA, GUYANA, INDIA, INDONESIA, IRAQ, ITALY, JAPAN, JORDAN, KAZAHSTAN, KOREA, KUWAIT, LATVIA, MYANMA, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, ROMANIA, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, THAILAND, TURKEY, UKRAINE, UZBEKISTAN, and VIETNAM.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = GE MEDICAL SYSTEMS, LLC
-
-