Technical Name: Fixed X-ray Apparatus ANVISA Registration Number: 80071260010 Hazard Class: III Model Affected: Prestige II Serial Numbers Affected: PRESTIGE II X-RAY SYSTEM (Registration on ANVISA: 80071260010); PRESTIIX 1600 E X-RAY SYSTEM (Registration with ANVISA: 10310650033); X-RAY SYSTEM PRESTIGE SI AND PRESTIGE VH (Registration with ANVISA: 10310650014); X - LEGACY D SYSTEM (Registration with ANVISA: 10310650029); ADVANTX SFX X-RAY SYSTEM (Registration with ANVISA 10310650031); DIGITAL IMAGE SYSTEM BY X-RAY INNOVA (Model: INNOVA 2000 - Registration at ANVISA 80071260060)