FDA recall Z-2707-2017

Product

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

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.

Distribution

Distribution US nationwide.

Key facts

Status

Terminated

Initiation date

2016-03-10

Report date

2017-07-19

Termination date

2020-03-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hartland, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2707-2017