Vital sign monitors recalled over blood pressure measurement error messages
Schiller is recalling 266 Argus PB-3000 vital sign monitors that may trigger an error message during blood pressure measurement when initial inflation pressure is set high.
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: Scored 2 because the stated effect is an error message during measurement, with no hazard, incorrect reading or injury described in the record.
Plain-English summary
Argus PB-3000 vital sign monitoring instruments, reference numbers 1A.701307, 3.921002, 3.921030, 3.921031 and 3.921006, are being recalled because the instrument may trigger an error message during blood pressure measurements, specifically when the initial inflation pressure is set in the high-pressure range.
The recall covers 266 units distributed in Montana, Wisconsin and Illinois. The FDA has classified the action as Class II.
The enforcement record describes the error message and does not state any injury or patient consequence. Facilities operating affected reference numbers should follow Schiller's instructions.
The recalled product
- Product
- Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
- Manufacturer
- Schiller, Ag
- Category
- Medical Device — Patient monitor
- Hazard
- error-message
- measurement-interruption
- device-defect
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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