FDA-Device2017-06-21Class II
GE Healthcare lnnova IGS 540 ACT X-ray system
GE Healthcare, LLC
Hazard
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Sold states
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.
Affected count
10,884
Manufactured in
3000 N Grandview Blvd, N/A, Waukesha, WI, United States
Products
GE Healthcare lnnova IGS 540 ACT X-ray system
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2187-2017Don't want to check this manually?
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