100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
US (Domestic) distribution to states of: WA, GA, and IL. OUS (International) distribution to Japan and Netherlands.
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0807-2025