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

Recall date

March 10, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2707-2017

FDA classification

Class II

Brand / firm

Merge Healthcare, Inc.

Sold / distributed

Distribution US nationwide.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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