Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-2707-2017

March 10, 2016

Class II

Product summary

Firm
Merge Healthcare, Inc.
Event
Event 77086
Status
Terminated
Classification
Class II
Quantity
555 PDM's
Official record key
device-enforcement:Z-2707-2017

Official wording

Reason: 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.

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

Distribution pattern: Distribution US nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.