Northgate Technologies

9 recalls •

🏥 Medical Devices

• Categories: Other Medical Devices, Implants & Prosthetics, Surgical Instruments

AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe

Class I - Dangerous

Product labeled incorrectly.

Apr 13, 2022 Other Medical Devices Nationwide View Details →

Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.

Class I - Dangerous

The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.

Oct 25, 2021 Other Medical Devices View Details →

Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 710300 - Product Usage: designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

Class I - Dangerous

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

Jan 15, 2021 Implants & Prosthetics Nationwide View Details →

ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Product Usage: The device will maintain an expanded cavity (pneumoperitoneum) to allow the insertion of a variety of surgical instruments through the abdominal wall for visual examination of the interior or for surgery (laparoscopic surgery).

Class I - Dangerous

An internal tubing component in the flow path was made with incorrect material which was not tested for use with this device.

Jan 15, 2021 Surgical Instruments Nationwide View Details →

Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Class I - Dangerous

As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Mar 10, 2020 Other Medical Devices Nationwide View Details →

AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Class I - Dangerous

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Mar 10, 2020 Other Medical Devices Nationwide View Details →

ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, America (OSTA); NTI Catalog Number 72-00198-0 - Product Usage: Probes are used for the fragmentation of urinary/renal and biliary calculi.

Class I - Dangerous

Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.

Mar 10, 2020 Surgical Instruments Nationwide View Details →

Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used with a Model 9-201-00 Autolith lithotripter. electrohydraulic lithotripsy (EHL) is a method that allows large stones to be fragmented and removed percutaneously or endoscopically.

Class I - Dangerous

The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. According to Northgate Technologies, the resistor in the probe will not allow the mislabeled product to be used with the incorrect generator. Could Delay Care.

May 24, 2017 Other Medical Devices View Details →

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

Class I - Dangerous

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

Nov 21, 2016 Implants & Prosthetics View Details →