Device product
GE Healthcare Lightspeed RT16 X-ray system
Z-2189-2017
Product summary
- Event
- Event 77377
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,884
- Official record key
device-enforcement:Z-2189-2017
Official wording
Reason: It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.
Code information: n/a
Distribution pattern: 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.
Derived failure modes
-
Unknown
It was discovered that an issue has been identified that can result in a scan starting before the prescribed delay has completed.