ARGUS PB-3000 recallZ-2672-2025 · Schiller, Ag · initiated Aug 8, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Schiller, Ag or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
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
Recall details
- Recall number
- Z-2672-2025
- Status
- Open, Classified
- Initiated by the company
- Aug 8, 2025
- Posted by the FDA
- Sep 29, 2025
- Recalling firm
- Schiller, Ag
- Quantity
- 266 units
- Product code
- MHX
- FDA submissions
- K221056
- Distribution
- US Nationwide distribution in the states of MT, WI, IL.
Product description
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Code information (models, lots, serial numbers)
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
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- ARGUS PB-3000 PB-3000 Var.7, sub-variant: SAGSchiller AG · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- ARGUS PB-3000 PB-3000 Var.7, sub-variant: M/ISchiller AG · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- ARGUS PB-3000 PB-3000 Var.7, sub-variant: CSchiller AG · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- ARGUS PB-3000 PB-3000 Var.8, sub-variant: QSchiller AG · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
- ARGUS PB-3000 PB-3000 Var.9, sub-variant: QSchiller AG · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 recall0 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K221056 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Schiller ECG wire set 2.410308Schiller AG · Cable, Transducer And Electrode, Patient, (Including Connector)1 report
- ARGUS PB-3000 PB-3000 Var.10, sub-variant: M/ISchiller AG · Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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