For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment.
Reason for recall: For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to incorrect diagnosis and treatment. Distribution: Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan Quantity: 29 units Lot/code info: UDI-DI: (01)00884838059450 Serial Numbers: Serial Number 7362 75114 7441 7449 7996 7104 7333 7991 7497 7762 7254 7373 7674 7783 7971 7802 7385 7840 7353 750010 75107 8007 7990 7716 7689 7618 75045 7442 750017
00884838059450
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.