Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Recall
- Recall Number
- Z-2672-2025
- Event Number
- 97451
- Firm
- Schiller, Ag Altgasse 68 Baar Switzerland
- FEI Number
- 3002808182
- Product Code
- MHX
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 8, 2025
- Posted
- September 29, 2025
Description
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
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.
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
US Nationwide distribution in the states of MT, WI, IL.
266 units