Recall Z-2707-2017— Merge Healthcare, Inc.

Name: FDA recall Z-2707-2017
Creator: U.S. Food and Drug Administration
Published: 2016-03-10

Class II · Terminated

Class II FDA medical device recall by Merge Healthcare, Inc., initiated 2016-03-10, terminated 2020-03-06. It names one FDA 510(k) clearance: K082421. Product: The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.. 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..

Recalling firm: Merge Healthcare, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-03-10
Terminated: 2020-03-06
Firm location: Hartland, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082421 — HEARTSUITE HEMODYNAMICS 7.10Emageon, Inc.·cleared 2008-12-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.