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Northgate Technologies, Inc. recalls Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices t
Recalled December 28, 2016 · FDA recall Z-0866-2017 · Northgate Technologies
Hazard
Device could cause a patient overpressure situation without any visual or auditory indication or warning · FDA Class II
Units
49 devices
Sold at
Worldwide Distribution - US including FL and MA. Internationally to Canada
Description
Device could cause a patient overpressure situation without any visual or auditory indication or warning
Product
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
Manufacturer(s)
Northgate Technologies, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →