BEUDAMED
    FDA Recall Terminated

    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures

    Recall: Z-0866-2017 · Initiated November 21, 2016

    Recall

    Recall Number
    Z-0866-2017
    Event Number
    75716
    Firm
    Northgate Technologies, Inc.
    FEI Number
    1450997
    Product Code
    HIF
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 21, 2016
    Terminated
    November 27, 2017
    Address
    1591 Scottsdale Ct, Elgin, IL, 60123-9361

    Description

    Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical cavities for diagnostic and/or operative endoscopy. The insufflator has multiple operating modes which can be used for the following procedures: General Laparoscopic, Pediatric Laparoscopic, Bariatric Laparoscopic and Minimally Invasive Vessel Harvesting procedures

    Reason

    Device could cause a patient overpressure situation without any visual or auditory indication or warning

    Action

    Northgate Technologies sent an Urgent Medical Device Recall Notification letter dated November 17, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customers. Customers were instructed to examine their records and ascertain the location of affected devices, cease distribution or use and quarantine those products appropriately. Ship all affected products in their possession to Northgate Technologies, Inc., 1591 Scottsdale Court, Elgin, IL 60123. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 847-608-9405. If product was further distributed, those customers should be notified immediately. Customers with questions should call 224-856-2253. For questions regarding this recall call 800-348-0424.

    Distribution

    Worldwide Distribution - US including FL and MA. Internationally to Canada

    Quantity

    49 devices