HIGH

Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006

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.

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Schiller, Ag or your healthcare provider for instructions. Notification method: Letter

Full Description

Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006. 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.. Classification: Class II. Quantity: 266 units. Distribution: US Nationwide distribution in the states of MT, WI, IL.

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Product Classification

Product Details

Model 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
+2 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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