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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 266
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
Related recalls
Same manufacturer · Schiller, Ag
See all →- HighElectrocardiograph Recall: CARDIOVIT AT-180 May Produce Signal Artifacts
FDA (Devices) · 2024-09-04
Same hazard · error message
See all →- ModerateBaxter SIGMA Spectrum Infusion Pump Software Anomaly Recall
FDA (Devices) · 2017-04-05
Other medical device recalls
- ModerateMedline Medical Convenience Kits Recalled for Adhesive Removal Issues
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters for Coating Defects
FDA (Devices) · 2026-10-28
- ModerateBoston Scientific Recalls Direxion Torqueable Microcatheters Due to Coating Defects
FDA (Devices) · 2026-10-28
- ModerateMedtronic NDI Passive Spheres Recalled for Reflective Material Variation
FDA (Devices) · 2026-10-28
- ModerateThink Surgical Square Driver Recalled for Design Specification Failures
FDA (Devices) · 2026-10-28
Similar recalls
- ModerateHemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
FDA (Devices) · 2025-09-10
- HighMediana Attendant Vital Signs Monitor Recalled for Temperature Measurement Failures
FDA (Devices) · 2020-07-08
- ModerateA&D Blood Pressure Monitors Recalled for Small Cuff Labeling Error
FDA (Devices) · 2016-10-19
- HighPhilips IntelliVue X3 Patient Monitor Recalled for Blood Pressure Display Errors
FDA (Devices) · 2018-04-18
- HighMediana Vital Signs Monitor May Fail to Power Up or Respond
FDA (Devices) · 2021-07-28
- ModeratePhilips Recalls MRI Patient Monitoring Systems Due to Incorrect Calibration Instructions
FDA (Devices) · 2020-04-08