Device product
Argus PB-3000, Reference Numbers: 1A.701307,3.921002, 3.921030,3.921031, 3.921006
Z-2672-2025
Product summary
- Firm
- Schiller, Ag
- Event
- Event 97451
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 266 units
- Official record key
device-enforcement:Z-2672-2025
Official wording
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.
Code information: 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 pattern: US Nationwide distribution in the states of MT, WI, IL.
Derived failure modes
-
Unknown
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.