Merge Healthcare, Inc.: Medical Device Recall in 2017 - (Recall #: Z-2707-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

Product Classification:

Class II

Date Initiated: March 10, 2016

Date Posted: July 19, 2017

Recall Number: Z-2707-2017

Event ID: 77086

Reason for Recall:

If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.

Status: Terminated

Product Quantity: 555 PDM's

Code Information:

All Schiller PB-1000 PDM's distributed on or before 8/11/2016.

Distribution Pattern:

Distribution US nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated