Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2707-2017 — The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.

U.S. FDA — Device Enforcement · United States · 2016-03-10 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2707-2017
Date of alert
2016-03-10
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Merge Healthcare, Inc.
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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