GE Optima CT520 and Optima CT540 Computed Tomography (CT) systems. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
FDA Recall Z-0840-2014 · Posted 2014-01-27
Recalling FirmGE Healthcare, LLC
Recall StatusTerminated
Product CodeJAK
Date Initiated2013-10-09
Date Terminated2014-06-19
Product Quantity272 (29 US; 243 OUS)
Reason for Recall
There is an issue with the Manual Film Composer feature on some CT products. There is an opportunity, while following a specific workflow, to create a film image with one patient's images and another patient's name in the footer. This is also an issue when within Manual Film Composer, if a color image is selected for printing, another patient's black and white image appears in the preview screen
Firm Action
Consignees were sent on 10/9/2013 a GE Healthcare "Urgent Medical Device Correction" letter dated October 9, 2013. The letter was addressed to Hospital Administrators / Risk Managers, Radiology Directors and Radiologists. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (Contact your local GE Healthcare Service Representative or the GE Healthcare Call Center : US or Canada : 800-437-1171 and Other countries: 262-896-2890).
Root Cause
Software design
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of AL, CO, FL, IN, KS, KY, MN, NC, OH, TX, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BULGARIA, CANADA, CHINA, ABIDJAN COTEDIVOIRE EGYPT, FRANCE, GERMANY, GREAT BRITAIN, INDIA, IRAQ, ITALY, JAPAN, KENYA, LATVIA, LEBANON, MALAYSIA, MARTINIQUE,MOROCCO, NEW ZEALAND, NORWAY, PAKISTAN, POLAND, PORTUGAL ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWITZERLAND, THAILAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and VIETNAM.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.