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

Class 2 Device Recall GE, Optima CT660

  • 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, Optima CT660 see related information
Date Posted October 17, 2013
Recall Status1 Terminated on December 05, 2013
Recall Number Z-0023-2014
Recall Event ID 65958
510(K)Number K110227 
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product GE, Optima CT660.

Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data.
Code Information YC7
00000047739YC8
00000048007YC9
00000048015YC2
00000038737YC3
00000040369YC1
00000040617YC3
00000040817YC9
00000041146YC2
00000042452YC3
00000046725YC8
00000040614YC0
00000040615YC7
00000047326YC4
00000047328YC0
00000048009YC5
00000047323YC1
00000047989YC9
00000047990YC7
00000048006YC1
00000039805YC7
00000042013YC3
00000043739YC2
00000043903YC4
00000043741YC8
00000045605YC3
00000040816YC1
00000042448YC1
00000044151YC9
00000044642YC7
00000045604YC6
00000045908YC1
00000047060YC9
00000316556HM0
00000431438CN1
00000308949HM7
00000321951HM6
00000280831HM9
00000280832HM7

00000327466HM9
00000305381HM6
00000315022HM4
00000301347HM1
00000327366HM1
00000034263YC4
00000307766HM6
00000321952HM4
00000296970HM7
00000301346HM3
00000326337HM3
00000326862HM0
00000327463HM6
00000033194YC2
00000328078HM1
00000041535YC6
00000041536YC4
00000041537YC2
00000304638HM0
00000304639HM8
00000304750HM3
00000305868HM2
00000305870HM8
00000306523HM2
00000306524HM0
00000306945HM7
00000306946HM5
00000306947HM3
00000307767HM4
00000308320HM1
00000308322HM7
00000311078HM0
00000311877HM5
00000311878HM3
00000312780HM0
00000312782HM6
00000298210HM6
00000302021HM1
00000305867HM4
00000304640HM6
00000308947HM1
00000310014HM6
00000317418HM2
00000034384YC8
00000315827HM6
00000045608YC7
00000044640YC1
00000430273CN3
00000305869HM0
00000430875CN5
00000324510HM7
00000329532HM6
00000312779HM2
00000039003YC9
00000038738YC1
00000044152YC7
00000308321HM9
00000310568HM1
00000034790YC6
00000031572YC1
00000293945HM2
00000321953HM2
00000322642HM0
00000325265HM7
00000325266HM5
00000037282YC1
00000038740YC7
00000040818YC7
00000041827YC7
00000042804YC5
00000043481YC1
00000043740YC0
00000044526YC2
00000044638YC5
00000044639YC3
00000044641YC9
00000044643YC5
00000044860YC5
00000045065YC0
00000315828HM4
00000315829HM2
00000316790HM5
00000296971HM5
00000044644YC3
00000045066YC8
00000316769HM9
00000320005HM2
00000296968HM1
00000047630YC9
00000048012YC9
00000041829YC3
00000042450YC7
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
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 380 (52 US & 328 OUS)
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 = JAK and Original Applicant = GE MEDICAL SYSTEMS, LLC
-
-