Events

Recall of Device Recall The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM),

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Merge Healthcare, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    77086
  • Event Risk Class
    Class 2
  • Event Number
    Z-2707-2017
  • Event Initiated Date
    2016-03-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154942
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Computer, diagnostic, programmable, cardiovascular - Product Code DQK
  • 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.
  • Action
    The recalling firm issued recall letters dated 3/10/2016, 5/3/2016, and 8/5/2016 via email or via certified mail if the email address is not available.

Device

Device Recall The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM),
  • Model / Serial
    All Schiller PB-1000 PDM's distributed on or before 8/11/2016.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distribution US nationwide.
  • Product Description
    The Schiller PB 1000, also known as Merge Hemo Patient Data Module (PDM), a major component of the Merge Hemo software.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.