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FDAMarch 10, 2016device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

merge healthcaremerge

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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