Events

Recall of Device Recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit),

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
    76946
  • Event Risk Class
    Class 2
  • Event Number
    Z-1923-2017
  • Event Initiated Date
    2015-03-30
  • Event Date Posted
    2017-05-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154651
  • 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 - Product Code DQK
  • Reason
    The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. this could result in the potential of a small bias added to the co2 measurement and affect the alarm notification.
  • Action
    The recall was initiated by telephone on March 30, 2015. Follow-up phone calls were made July 6, 2015. The firm was unable to provide a telephone script. The recalling firm also issued letters dated March 28, 2016, via email on April 6, 2016, dated July 11, 2016. The letters contained the same content, notified the customer of the issue, and informed them a fix was available. The notification instructs the customer to pass the information onto all other users, as well as any downstream customers if it was further distributed. The notification also informs the customer their response is required using the enclosed form and the return addressed envelope. The response form asks, in part, if they have the affected ISA CO2 sensors at their facility and are they interested in accepting the fix. If they decline the fix, they are asked to provide the reason why. For further questions, please call (877) 741-5369.

Device

Device Recall Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit),
  • Model / Serial
    ISA CO2 Sensor serial numbers:  107349, 107357, 107358, 107363, 107370, 107377, 107390, 107407, 107435,  107476, 107509, 107510, 107556, 107659, 107700, 107707, 107768, 107776,  107831, 107832, 107836, 107839, and 107841.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution was made to medical facilities located in AL, FL, ID, LA, MO, NC, OK, SC, TX, and UT. There was government distribution and no foreign/military distribution.
  • Product Description
    Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-00001. The PhaseIn Unit is an optional accessory (sold separately) to the Merge Hemo Patient Data Module (PDM). The PDM is a major component of the Merge Hemo system.
  • Manufacturer
    Merge Healthcare, Inc.

Manufacturer

Merge Healthcare, Inc.