Northgate Technologies, Inc.: 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 number

Z-0866-2017

Recalling firm

Northgate Technologies, Inc.

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

Status

Terminated

Initiated

2016-11-21

Posted

not on file

Terminated

2017-11-27

Reason

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

Root cause

Software design

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.

Quantity

49 devices

Distribution

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

Lot, serial or model codes

Serial Numbers: #89170HXB, #89556DYD, #89652FYA, #89661FYA, #89663FYA, #89664FYA, #89670FYA, #89672FYA, #89675FYA, #89677FYA, #89685FYB, #89697FYB, #89708GYA, #89713GYA, #89719GYB, #89720GYB, #89729GYB, #89732GYB, #89734GYB, #89737GYB, #89889IYD, #90165AZB, #90285BZD, #90387DZB, #90391DZB, #90415DZD, #90438DZD, #90469EZB, #90528EZD, #90555FZB, #90556FZB, #90557FZB, #90558FZB, #90561FZB, #90583GZC, #90621GZB, #90654HZB, #90739IZD, #90869KZD, #90931LZD, #90936LZD, #90954LZD, #90962LZD, #90972LZD, #91105CAD, #91108CAD, #91114CAD, #91120CAD, #91380FAC, #91406FAD, #91471GAC, #91544IAC

510(k) numbers

["K120151"]

PMA numbers

not on file

Product code

HIF

Firm FEI

1450997

Firm city

Elgin

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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