Recall Z-2241-2013 ยท LLZ System, Image Processing, Radiological
GE Healthcare, LLC
GE Healthcare, Advantage Workstation, READY View Application. Image analysis software.
| Date | Sep 18, 2013 (initiated Mar 27, 2012) |
| Status | Terminated |
| Reason | GE Healthcare has become aware that when analyzing fMRI images using the READY View application software, incorrect fMRI activation maps may be computed and displayed. |
| Root cause | Software design |
| Action | GE provided Urgent Medical Device Correction letters to consignees in the following countries: Canada, Finland, France, Germany, Guadeloupe, Italy, Japan, Latvia, Martinique, Netherlands, Norway, Poland, Reunion, Romania, Saudi Arabia, Singapore, Spain,Sweden, Switzerland, Turkey and the United Kingdom. The letters were dated March 27, 2012 and were addressed to Hospital Administrators, Radiology Mangers and Risk Managers. The letters described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information (US 800-437-1171, Japan 0120-055-919 and |
| Quantity | 318 (28 USm 290 OUS) |
| Distribution | Worldwide Distribution-USA including the states of IL, MN, NJ, NY, and VA, and the countries of ALGERIA, AUSTRALIA, BELGIUM, BRAZIL, CANADA, DENMARK, FINLAND, FRANCE, GERMANY, GUADELOUPE, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN,KOREA, LATVIA, MARTINIQUE, NETHERLANDS, NORWAY, PHILIPPINES,S POLAND, REU |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110573 | READY VIEW Ge Healthcare (Ge Medical Systems Scs), May 3, 2011 |