Skip to content
RecallWatchMedical Device Safety
Manufacturer

Merge Healthcare, Inc. recalls

The FDA has posted 6 enforcement recalls from Merge Healthcare, Inc. since 2025, none of them Class I (most serious). Most recent report: Sep 10, 2025.

Class II: 6
Class IIOngoingZ-2518-2025

Merge Healthcare, Inc. recalls Merge Hemo

Merge Healthcare has been informed by Schiller AG (Baar, Switzerland) of an issue with the Schiller ARGUS PB-3000 Patient Data Module (PDM) where certain units trigger an error message on the Merge Hemo Client (Pressure…

  • Programmable Diagnostic Computer
  • Process control
Merge Healthcare, Inc.WISep 10, 2025
Class IIOngoingZ-1398-2025

Merge Healthcare, Inc. recalls VERICIS

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may…

  • Radiological Image Processing System
  • Software design
Merge Healthcare, Inc.WIMar 26, 2025
Class IIOngoingZ-1399-2025

Merge Healthcare, Inc. recalls VERICIS

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may…

  • Radiological Image Processing System
  • Software design
Merge Healthcare, Inc.WIMar 26, 2025
Class IIOngoingZ-1402-2025

Merge Healthcare, Inc. recalls Merge Cardio

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may…

  • Radiological Image Processing System
  • Software design
Merge Healthcare, Inc.WIMar 26, 2025
Class IIOngoingZ-1401-2025

Merge Healthcare, Inc. recalls VERICIS

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may…

  • Radiological Image Processing System
  • Software design
Merge Healthcare, Inc.WIMar 26, 2025
Class IIOngoingZ-1400-2025

Merge Healthcare, Inc. recalls VERICIS

When following a specific less typical workflow in which the user remeasures using the ultrasound device or manually edits primitive or derived measurement values directly in Clinical Reporting, derived measurements may…

  • Radiological Image Processing System
  • Software design
Merge Healthcare, Inc.WIMar 26, 2025

Firm name as filed with the FDA: “Merge Healthcare, Inc.”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.