Hemodynamic recording systems recalled over pressure sensor error during blood pressure measurement
Merge Hemo systems are recalled because certain Schiller ARGUS PB-3000 patient data modules trigger a Pressure Sensor Defective error during non-invasive blood pressure measurement above 240 mmHg. 84 units are affected.
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: Rubric level 2 covers precautionary recalls; the stated effect is an error message during a specific measurement setting, with no patient harm described.
Plain-English summary
The Merge Hemo, model RCSV2, model and catalog number 99-01172-00, software versions 11.1 and 11.1.1, is being recalled. The device is a hemodynamics recording computer system that monitors, measures, displays, records and stores vital signs data. Affected Schiller ARGUS PB-3000 serial numbers are listed in the recall notice. The recall covers 84 units distributed nationwide in the United States.
Merge Healthcare was informed by Schiller AG of an issue with the Schiller ARGUS PB-3000 Patient Data Module, where certain units trigger an error message on the Merge Hemo Client reading Pressure Sensor Defective during non-invasive blood pressure measurements, specifically when the initial inflation pressure is set in the high-pressure range above 240 mmHg. The notice states no other components of the Merge Hemo System are affected. The FDA classified the action as Class II.
Hospitals operating these systems should follow the manufacturer's instructions for affected patient data modules.
The recalled product
- Product
- Merge Hemo, Model RCSV2, Model/Catalog Number 99-01172-00, software versions 11.1 and 11.1.1 Product Description: The Merge Hemo, Model RCSV2 device is a hemodynamics recording computer system that monitors, measures, displays, records and stores various physiologic and blood fl
- Manufacturer
- Merge Healthcare, Inc.
- Hazard
- sensor-error
- blood-pressure
- patient-monitoring
- class-ii
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 (20)
- Schiller Model Name: ARGUS PB-3000
- Schiller Model #: 3.921002
- Affected PB-3000 Serial Numbers: 7012.000035
- 7012.000036
- 7012.000037
- 7012.000038
- 7012.000041
- 7012.000042
- 7012.000044
- 7012.000045
- 7012.000046
- 7012.000047
- 7012.000048
- 7012.000050
- 7012.000051
- 7012.000052
- 7012.000053
- 7012.000057
- 7012.000058
- 7012.000059
Distribution
Distributed nationwide across the United States.
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