BEUDAMED
    FDA Recall Terminated

    Oscar 2, Model 250 System

    Recall: Z-2429-2020 · Initiated April 20, 2020

    Recall

    Recall Number
    Z-2429-2020
    Event Number
    85515
    Firm
    Suntech Medical, Inc.
    FEI Number
    1036863
    Product Code
    DXN
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    April 20, 2020
    Terminated
    June 13, 2023
    Address
    507 Airport Blvd, Ste 117, Morrisville, NC, 27560-8200

    Description

    Oscar 2, Model 250 System

    Reason

    The device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg.

    Action

    Suntech Medical Instruments, Inc. notified customers on about [DATE] via "URGENT: MEDICAL DEVICE RECALL" letter. Customers were informed that the device display, when activated, can show an incorrect decimal point when the blood pressure reading is a three-digit number and the unit of measure is set for mmHg. Suntech Medical is instructing physicians and nurses that they can still use the device and are to ignore the readings on the device display and to continue to focus on the Accuwin Pro data for diagnosis. Best practice is to disable the device display during unit configuration and to instruct the patient to ignore any data that may be visible on the display. If these steps are followed, Suntech states the device can continue to be used. The correction will include 2 options: 1. To download the service tool at https://www.suntechmed.com/oscar2-display-update-request; or 2. Customers should contact SunTech to confirm the configuration has been corrected at [email protected] and provide the contact person, company name, and serial numbers of corrected devices. Additionally, customers were requested to complete and return the response form via email to [email protected], or they can be sent by mail to: Recall Coordinator, SunTech Medical, Inc., 507 Airport Blvd, suite 117, Morrisville, NC 27560-8200. Questions can be addressed to SunTech Medical at Email: [email protected], Phone: +1-800-421-8626 or 919-654-6128

    Distribution

    Nationwide distribution to CA, CT, FL, IL, LA, MD, NC, NY, OH, PA, PR, SC, TN, TX, UT. Worldwide distribution to Australia, Austria, Belgium, Bermuda, Brazil, Canada, Croatia, Czech Republic, Dominican Republic, Estonia, France, India, Ireland, Latvia, Lebanon, Morocco, Pakistan, Peru, Poland, Saudi Arabia, Singapore, South Africa, Spain, Taiwan, United Kingdom, Vietnam.

    Quantity

    1,037 units