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GE Healthcare, LLC recalls GE Healthcare Optima CT520 X-ray system
Recalled June 21, 2017 · FDA recall Z-2185-2017 · GE Healthcare
Hazard
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed. · FDA Class II
Units
10,884
Sold at
Worldwide Distribution - USA (nationwide) including Puerto Rico and to the countries of : Japan, Jordan, Kazakhstan, Korea ( Republic of) Kuwait, Latvia, Lebanon, Libya, Lithuania, Macedonia, Malaysia, Malta, Martinique, Mauritania, Mexico, Moldova, Morocco, Nambia, Netherlands, New Caledonia, New Zealand, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Republic of Serbia, Reunion, Romania, Russia, Rwanda, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Vietam and Yemen.
Description
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Product
GE Healthcare Optima CT520 X-ray system
Manufacturer(s)
GE Healthcare, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →