Recall Z-2672-2025 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Schiller, Ag
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
| Date | Sep 29, 2025 (initiated Aug 8, 2025) |
| Status | Open, Classified |
| 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. |
| Root 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 |
| Quantity | 266 units |
| Distribution | US Nationwide distribution in the states of MT, WI, IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K221056 | ARGUS PB-3000 Schiller AG, Jul 6, 2023 |