Class 2 Device Recall Argus PB3000

• Date Initiated by Firm: August 08, 2025
• Date Posted: September 29, 2025
• Recall Status: Open, Classified
• Recall Number: Z-2672-2025
• Recall Event ID: 97451
• 510(K)Number: K221056
• Product Classification: Monitor, physiological, patient(with arrhythmia detection or alarms) - Product Code MHX
• Product: Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
• 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
• FEI Number: 3002808182
• Recalling Firm/ Manufacturer: Schiller, Ag; Altgasse 68; Baar Switzerland
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• 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
• Quantity in Commerce: 266 units
• Distribution: US Nationwide distribution in the states of MT, WI, IL.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = MHX