Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
FDA device recall Z-2672-2025 · posted 2025-09-29 · Open, Classified
Recall details
- Recalling firm
- Schiller, Ag
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- MHX
- Quantity affected
- 266 units
- Distribution
- US Nationwide distribution in the states of MT, WI, IL.
- Date initiated
- 2025-08-08
- Date posted
- 2025-09-29
- Location
- Baar, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARGUS PB-3000 (K221056) | Schiller AG | 2023-07-06 |