FDA recall Z-2672-2025

Schiller, Ag · Class II · device

Product

Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

Reason for recall

Vital sign monitoring instrument may trigger an error message during blood pressures measurements, Specifically, when the initial inflation pressure is set in the high-pressure range.

Distribution

US Nationwide distribution in the states of MT, WI, IL.

Key facts

Status: Ongoing
Initiation date: 2025-08-08
Report date: 2025-10-08
Voluntary/Mandated: Voluntary: Firm initiated
Location: Baar, N/A, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2672-2025