Blood pressure monitor may trigger error message during high-pressure inflation
Schiller's Argus PB-3000 blood pressure monitor may display an error message during measurements when initial inflation pressure is set to high levels. Approximately 266 units were distributed in Montana, Wisconsin, and Illinois.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or deaths. The hazard is a functional defect that may trigger an error message during measurements, creating an operational issue rather than direct patient harm. Per the severity rubric, Class II recalls without reported injury or hospitalization are scored as Moderate.
Plain-English summary
Schiller, Ag is recalling the Argus PB-3000 vital sign monitoring instrument. The device may trigger an error message during blood pressure measurements when the initial inflation pressure is set in the high-pressure range.
This functional defect affects the device's normal operation during certain measurements. The issue was identified in specific serial numbers across multiple product variants identified by reference numbers and UDI codes.
Approximately 266 units were distributed nationwide in Montana, Wisconsin, and Illinois. Affected serial numbers include 7010.000160 and lower, 7012.000356 and lower, 7013.000256 and lower, and 7014.000152 and lower, depending on the specific product reference number.
Patients and healthcare providers using an affected Argus PB-3000 should contact Schiller, Ag for further guidance on device service, repair, or replacement options.
The recalled product
- Product
- Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
- Manufacturer
- Schiller, Ag
- Hazard
- device-malfunction
- measurement-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
Distributed nationwide across the United States.
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