Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
FDA Recall Z-2672-2025 · Posted 2025-09-29
Recalling FirmSchiller, Ag
Recall StatusOpen, Classified
Product CodeMHX
Date Initiated2025-08-08
Product Quantity266 units
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.
Firm Action
On August 8, 2025, Schiller AG issued an Field Safety Notice to affected consignees via E-Mail. On September 6, 2025, Schiller issued a "Urgent Medical Device Recall Expansion their recall to additional products. Schiller asked consignees to take the following actions:
1. Read the Field Safety Notice (FSN) provided by the system manufacturer carefully
2. Wait until your system manufacturer contacts you for device testing or to arrange the remediation of your device(s).
3. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. (As appropriate)
4. Please transfer this notice to other organizations on which this action has an impact. (As appropriate)
5. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
Please report all device-related incidents
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide distribution in the states of MT, WI, IL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.