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

FDA Recall #Z-2672-2025 — Class II — August 8, 2025

Recall #Z-2672-2025 Date: August 8, 2025 Classification: Class II Status: Ongoing

Product Description

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.

Recalling Firm

Schiller, Ag — Baar, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

266 units

Distribution

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

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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