Z-0866-2017Class II

Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are...

Name: Z-0866-2017 Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are...
Creator: Northgate Technologies, Inc.
Published: 2016-11-21
License: https://open.fda.gov/license/

Northgate Technologies Inc. / initiated 2016-11-21 / Terminated / root cause: software

FDA source

Northgate Technologies, Inc. began a recall of Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 50L and Nebulae I insufflators are devices that provide CO2 gas distention of surgical... on 2016-11-21. FDA classified it as Class II and gives the reason as "Device could cause a patient overpressure situation without any visual or auditory indication or warning". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0866-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-21
Posted: 2016-12-21
Terminated: 2017-11-27
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
Product code: HIF Insufflator, Laparoscopic
Reason for recall: Device could cause a patient overpressure situation without any visual or auditory indication or warning
Root cause tag: software
FDA 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 in commerce: 49 devices
Distribution: Worldwide Distribution - US including FL and MA. Internationally to Canada
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0866-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0866-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-21

Product code HIF

K120151Class IINebulae INorthgate Technologies, Inc. / cleared 2012-08-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)