Recall Z-0866-2017 ยท HIF Insufflator, Laparoscopic
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 V
| Date | Nov 21, 2016 |
| Status | Terminated |
| 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 |
| Quantity | 49 devices |
| Distribution | Worldwide Distribution - US including FL and MA. Internationally to Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K120151 | NEBULAE I Northgate Technologies, Inc., Aug 17, 2012 |