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GE Healthcare, LLC recalls GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Recalled September 14, 2016 · FDA recall Z-2731-2016 · GE Healthcare
Hazard
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue. · FDA Class II
Units
383 (US = 24;OUS = 359)
Sold at
US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
Description
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
Product
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →