Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2672-2025

August 08, 2025

Class II

Product summary

Firm
Schiller, Ag
Event
Event 97451
Status
Ongoing
Classification
Class II
Quantity
266 units
Official record key
device-enforcement:Z-2672-2025

Official wording

Reason: 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.

Code information: REF: 1A.701307: UDI- 07613365003024 REF: 3.921002, UDI: 07613365001914 REF: 3.921030, UDI: 07613365003468 REF: 3.921031: UDI: 07613365003475 REF: 3.921006, UDI: 07613365000115 Affected Serial Numbers: 7010.000160 and lower, 7012.000356 and lower, 7013.000256 and lower, 7014.000152 and lower

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.