Recall Z-2672-2025— Schiller, Ag

Name: FDA recall Z-2672-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-08

Class II · Ongoing

Class II FDA medical device recall by Schiller, Ag, initiated 2025-08-08. It names one FDA 510(k) clearance: K221056. Product: Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006. 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..

Recalling firm: Schiller, Ag
Classification: Class II
Status: Ongoing
Initiated: 2025-08-08
Firm location: Baar, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K221056 — ARGUS PB-3000Schiller AG·cleared 2023-07-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.