Autolith TouchRecalls & reported problems across all models
Northgate Technologies Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Autolith Touch model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 13
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 2 models of Autolith Touch by Northgate Technologies Inc. in the FDA's device registry (GUDID). Together they are named in 13 adverse event reports in the FDA's MAUDE database, received between Feb 5, 2020 and Mar 28, 2025 — classified as 13 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Autolith Touch recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Oct 25, 2021Open, Classified
The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
Z-0333-2022 · Root cause: Software design (manufacturing process) · Recall details · FDA record ↗
Most reported Autolith Touch problems
Device problems
- Detachment of Device or Device Component10
- Arcing of Electrodes1
- Break1
- Electrical /Electronic Property Problem1
- Increase in Pressure1
- Therapeutic or Diagnostic Output Failure1
- Unintended Electrical Shock1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Electric Shock1
- Insufficient Information1
- No Consequences Or Impact To Patient1
- Numbness1
Autolith Touch models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Autolith Touch M005466800Lithotriptor, Electro-Hydraulic1 recall12 reports
- Autolith Touch M0054668R0Lithotriptor, Electro-Hydraulic1 report
Recent Autolith Touch adverse event reports
The 13 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMar 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
ON 02/18/2025, NTI RECEIVED A COMPLAINT WHERE CUSTOMER REPORTED THAT "DURING PREPARATION IT WAS FOUND THAT THE EHL GENERATOR UNABLE TO GENERATE ANY PULSE". THE DEVICE WAS RECEIVED AT NTI ON 02/21/2025. DURING SERVICE EVALUATION OF THE DEVICE ON 03/03/2025, CUSTOMER COMPLAINT OF DEVICE NOT GENERATING PULSES WAS VERIFIED. IT WAS IDENTIFIED THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21724994 ↗MalfunctionJul 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 05/17/2024 NTI RECEIVED A COMPLAINT WHERE CUSTOMER REPORTED THAT "SCREEN DOES NOT POWER ON". THE DEVICE WAS RECEIVED AT NTI ON 06/03/2024. DURING SERVICE EVALUATION OF THE DEVICE ON 06/12/2024, CUSTOMER COMPLAINT OF "SCREEN DOES NOT POWER ON" WAS NOT CONFIRMED. HOWEVER, IT WAS IDENTIFIED THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19719971 ↗MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON (B)(6) 2024 CUSTOMER REQUESTED AN RMA TO RETURN THE DEVICE TO NTI FOR EVALUATION, NO COMPLAINT NOR MALFUNCTION WAS REPORTED. DURING THE SERVICE EVALUATION ON 02/15/2024 IT WAS IDENTIFIED THAT THE INSULATED WIRES FROM THE HIGH VOLTAGE TRANSFORMER WERE DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE AMONG A NUMBER OF OTHER INSTANCES OF PHYSICAL DAMAGE NOTED TO THE EXTERIOR AND INTERIOR OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913551 ↗MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ON 02/02/2024 CUSTOMER REPORTED THAT " THE PROBE DOES NOT DELIVER ENERGY" THE DEVICE WAS RECEIVED AT NTI ON 2/06/2024. DURING THE SERVICE EVALUATION ON 02/15/2024 IT WAS IDENTIFIED THAT THE INSULATED WIRES FROM THE HIGH VOLTAGE TRANSFORMER WERE DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE AMONG A NUMBER OF OTHER INSTANCES OF PHYSICAL DAMAGE NOTED TO THE EXTERIOR AND INTERIOR OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18913546 ↗MalfunctionNov 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 09/21/2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED MALFUNCTION OF THE DEVICE THAT PREVENT THE DEVICES FROM BEING USED (BLANK SCREEN). THE DEVICE WAS NOT RETURNED FOR EVALUATION UNTIL 09/28/2023. DURING THE SERVICE EVALUATION IT WAS IDENTIFIED THAT THE INSULATED WIRES FROM THE HIGH VOLTAGE TRANSFORMER WERE DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE DEVICE AMONG A NUMBER OF OTHER INSTANCES OF PHYSICAL DAMAGE NOTED TO THE EXTERIOR AND INTERIOR OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18112272 ↗MalfunctionJul 28, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ON 04/03/2023 NORTHGATE TECHNOLOGIES WAS MADE AWARE OF AN ALLEGED MALFUNCTION OF THE DEVICE THAT PREVENT THE DEVICES FROM BEING USED (THE DEVICE DID NOT FIRE). THE DEVICE WAS NOT RETURNED FOR EVALUATION UNTIL 6/14/2023. DURING THE SERVICE EVALUATION IT WAS IDENTIFIED THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED FROM THE HIGH VOLTAGE PCB WITHIN THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17415433 ↗MalfunctionJan 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
A DEVICE USED IN NON-CLINICAL DEMONSTRATIONS WITH NO RELATED COMPLAINTS WAS RETURNED FROM THE FIELD FOR PREVENTATIVE MAINTENANCE. DURING PREVENTATIVE MAINTENANCE IT IS NOTED THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER IS DISCONNECTED OR FOUND BROKEN FROM THE PRINTER CIRCUIT BOARD (LOOSE WIRE) WITHIN THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16244447 ↗MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE PREVENTATIVE MAINTENANCE OF THE DEVICE AT NORTHGATE TECHNOLOGIES, INC, IT WAS IDENTIFIED IN SERVICE EVALUATION THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED (WIRE BROKEN) FROM THE HIGH VOLTAGE PCB WITHIN THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14654105 ↗MalfunctionDec 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE PREVENTATIVE MAINTENANCE OF THE DEVICE AT NORTHGATE TECHNOLOGIES, INC, IT WAS IDENTIFIED IN SERVICE EVALUATION THAT THE INSULATED WIRE FROM THE HIGH VOLTAGE TRANSFORMER WAS DISCONNECTED (WIRE BROKEN) FROM THE HIGH VOLTAGE PCB WITHIN THE UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12961894 ↗MalfunctionSep 25, 2021Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure
NORTHGATE TECHNOLOGIES, INC WAS MADE AWARE OF AN ALLEGED ISSUE ON AN AUTOLITH DEVICE ON (B)(6) 2021, "WE HAVE HAD SEVERAL ISSUES WITH OUR AUTOLITH INVOLVING FUSES BLOWING DURING PROCEDURES. THIS HAPPENED AGAIN EARLIER THIS WEEK. WE HAD BIOMED INVOLVED DURING THE PROCEDURE, WHICH SIGNIFICANTLY LENGTHENED THE PROCEDURE AND ANESTHESIA TIME. THE PATIENT ULTIMATELY SUFFERED A PROCEDURAL COMPLICATION THAT IS REQUIRING EXTENDED HOSPITALIZATION...."
Patient problems: Insufficient Information
MAUDE report 12530863 ↗MalfunctionSep 10, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
DURING THE SERVICING OF A DEVICE FOR "AN UNKNOWN FAULT", IT WAS IDENTIFIED THAT THE HIGH VOLTAGE OUTPUT WIRE TO THE RESISTOR WAS DISCONNECTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12456570 ↗MalfunctionAug 19, 2021Electrical /Electronic Property Problem; Arcing of Electrodes; Electrical /Electronic Property Problem; Arcing of Electrodes
NORTHGATE TECHNOLOGIES, INC. (NTI) RECEIVED A DEVICE FOR EVALUATION WITH AN ALLEGED COMPLAINT OF "ONE OF THE PORTS IS ARCING ELECTRICAL...", THE COMPLAINT WAS CODED BY THE DISTRIBUTOR AS NO KNOWN IMPACT OR CONSEQUENCE TO PATIENT. INITIAL EVALUATION OF THE DEVICE INDICATED, THE UNIT HAD SIGNS OF FLUID INVASION WITHIN THE FRONT PANEL AND THE UNIT WAS RECEIVED WITH THE FUSES REMOVED FROM THE POWER MODULE. THE NATURE OF THE FLUID CONTAMINATION COULD NOT BE DETERMINED. WHEN THE UNIT WAS POWERED ON WITH NEW FUSES, THE DISPLAY, SPARK GAPS WITHIN THE UNIT, AND HV TRIGGER BOARD LED WERE FLASHING INVOLUNTARILY WITHOUT CONNECTION TO ANY EXTERNAL SOURCES ATTACHED TO THE UNIT WHICH IS ABNORMAL (THE DEVICE IS DESIGNED SUCH THAT THE SPARK GAPS SHOULD ONLY ACTIVATE UPON ACTIVATION OF THE ATTACHED FOOT PEDAL ACCESSORY). THERE WAS NO ACTUAL ARCING OR FIRING NOTED WITHIN THE UNIT OR OUTSIDE THE UNIT HOWEVER GIVEN THAT THE SPARK GAPS WERE OBSERVED TO BE FLASHING THIS INDICATES THAT POWER COULD / WAS BEING TRANSFERRED TO THE BULKHEAD CONNECTOR WITHOUT ANY ACTIVATION. THE DEVICE IS DESIGNED WITH A BULKHEAD CONNECTOR WHICH IS CONNECTED TO A REUSABLE EXTENDER CABLE WHICH IS THEN CONNECTED TO DISPOSABLE BI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12345816 ↗MalfunctionFeb 5, 2020Break; Increase in Pressure; Unintended Electrical Shock; Break; Increase in Pressure; Unintended Electrical Shock
ON 11/19/19 NTI WAS MADE AWARE OF THE FOLLOWING ALLEGED EVENT "IT WAS REPORTED THAT DURING AN ERCP THE PHYSICIAN STARTED USING THE EHL TO BREAK STONES, AND EVERYTHING WAS GOING LIKE ITS USED TO. AT A MOMENT, WHILE HE WAS BREAKING STONE, A NURSE WHO WERE INVOLVED IN THE CASE TO MANAGE PATIENT, RECEIVED WHAT SHE DESCRIBES AS AN ELECTRIC SHOCK. HER LEFT ARM WAS REALLY NEAR THE BELLY OF THE PATIENT. JUST AT THE LEVEL OF THE LIVER, WHERE THE PHYSICIAN WAS BREAKING STONES. SHE SAT DOWN A BIT, A LITTLE BIT CONCERNED BUT WITHOUT ANY PAIN OF FEELING SICK. SHE FELT A KIND OF NUMBNESS IN HER LEFT HAND. THIS SENSATION REMAINED FOR ABOUT AN HOUR ACCORDING TO HIS WORDS. SHE WAS ABLE TO CONTINUE WORKING IN THE CASE, CLOSELY TO THE PATIENT, WHILE THE PHYSICIAN WAS FINISHING TO BREAK THE STONE. AT A MOMENT, THE AUTOLITH TOUCH GENERATOR STOP WORKING, AND THIS MESSAGE BEEN DISPLAYED ON THE AUTOLITH KEYBOARD: REPORT FAULT CODE # 11 SERVICE UNIT ... SO AT THIS MOMENT, THE PHYSICIAN STOP USING THE EHL IN THIS CASE, AND COMPLETED THE CASE WITH REGULAR DEVICES LIKE BALLOON, BASKET, ETC. ALL THE STONES WERE BROKE, AND CBD WAS CLEARED AND PROCEDURE SUCCESSFUL ENDED FOR THE PATIENT. SO, AFTER THIS CASE, I RE
Patient problems: Electric Shock; No Consequences Or Impact To Patient; Numbness
MAUDE report 9671809 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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