Device product
Artis zeego, Model Number 10280959
Z-2034-2019
Product summary
- Event
- Event 83203
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117
- Official record key
device-enforcement:Z-2034-2019
Official wording
Reason: A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
Code information: Serial Numbers: 160395 160484 160502 160351 160392 160449 160463 160313 160411 160406 160106 160134 160136 160347 160312 160488 160448 160427 160455 160486 160435 160451 160346 160384 160100 160493 160391 160321 160376 160447 160471 160481 160401 160119 160403 160404 160501 160438 160388 160378 160419 160114 160450 160429 160149 160137 160152 160153 160154 160138 160446 160368 160394 160412 160387 160432 160147 160433 160483 160335 160402 160356 160425 160148 160337 160460 160485 160443 160461 160370 160381 160508 160122 160407 160325 160494 160390 160507 160144 160487 160418 160007 160001 160363 160341 160139 160430 160482 160006 160462 160520 160505 160445 160322 160323 160382 160421 160474 160116 160428 160131 160318 160357 160369 160498 160413 160414 160128 160373 160509 160551 160327 160338 160477 160519 160141 160469
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
A tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.