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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

FDA Recall Z-0866-2017 · Posted None

Recall StatusTerminated
Product CodeHIF
Date Initiated2016-11-21
Date Terminated2017-11-27
Product Quantity49 devices

Reason for Recall

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

Firm 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.

Root Cause

Software design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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