NOVADAQ and PINPOINTRecalls & reported problems across all models
Novadaq Technologies Inc · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls
- 0
We found 5 models of NOVADAQ and PINPOINT by Novadaq Technologies Inc in the FDA's device registry (GUDID). Together they are named in 29 adverse event reports in the FDA's MAUDE database, received between Sep 19, 2018 and Sep 14, 2026 — classified as 4 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (9 reports).
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
Most reported NOVADAQ and PINPOINT problems
Device problems
- Poor Quality Image9
- No Device Output4
- Temperature Problem4
- No Display/Image3
- Optical Problem3
- Adverse Event Without Identified Device or Use Problem2
- Electrostatic Discharge2
- Failure to Power Up2
Patient problems
- No Clinical Signs, Symptoms or Conditions20
- Electric Shock3
- Insufficient Information3
- No Known Impact Or Consequence To Patient3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
NOVADAQ and PINPOINT models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NOVADAQ and PINPOINT PC9000System, X-Ray, Angiographic17 reports
- NOVADAQ and PINPOINT SC9134System, X-Ray, Angiographic7 reports
- NOVADAQ and PINPOINT SC9534System, X-Ray, Angiographic3 reports
- NOVADAQ and PINPOINT SC9104System, X-Ray, Angiographic1 report
- NOVADAQ and PINPOINT SC9144System, X-Ray, Angiographic1 report
Recent NOVADAQ and PINPOINT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 14, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765758 ↗MalfunctionSep 9, 2026Fogging
It was reported that there was foggy image.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50681743 ↗InjuryAug 31, 2026No Display/Image; Poor Quality Image
It was reported that the customer had an issue with setting up the picture sharpness and the picture was vanishing during the procedure, that was probably caused due to a camera cable connection problem. The medical procedure was converted to a conventional laparotomy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50534175 ↗InjuryAug 28, 2026No Display/Image; Poor Quality Image
It was reported that the customer had an issue with setting up the picture sharpness and the picture was vanishing during the procedure, that was probably caused due to a camera cable connection problem. The medical procedure was converted to a conventional laparotomy.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50507209 ↗MalfunctionApr 22, 2026No Device Output; Overheating of Device
IT WAS REPORTED THAT LOUD POP NOISE DURING CASE AND IT STOPPED WORKING AND SMELT LIKE SOMETHING WAS BURNING. MY UNDERSTANDING IS THAT IT CAME FROM THE VPI. THEREFORE, THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24957016 ↗MalfunctionJan 17, 2024No Device Output; Temperature Problem; No Device Output; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18530806 ↗MalfunctionJan 4, 2023Electrostatic Discharge; Electrostatic Discharge
IT WAS REPORTED THAT THE USER RECEIVED AN ELECTRICAL SHOCK.
Patient problems: Electric Shock; Undesired Nerve Stimulation
MAUDE report 16098456 ↗MalfunctionOct 31, 2022Image Display Error/Artifact; Optical Problem; Image Display Error/Artifact; Optical Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15700410 ↗MalfunctionSep 24, 2022Image Display Error/Artifact; Temperature Problem; Image Display Error/Artifact; Temperature Problem
IT WAS REPORTED THAT THE LIGHT LEAD WAS VERY HOT, INDICATING A THERMAL EVENT. THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15478593 ↗MalfunctionAug 26, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THE IMAGE APPEARED BLURRY DURING A MEDICAL PROCEDURE. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE AND THERE WERE NO ADVERSE CONSEQUENCES AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15306987 ↗MalfunctionAug 25, 2022Failure to Power Up; No Display/Image; Failure to Power Up
IT WAS REPORTED THAT THE DEVICE LOST IMAGE DURING A PROCEDURE AND COULD NOT BE POWERED BACK ON. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15297972 ↗MalfunctionAug 18, 2022Failure to Power Up; Unexpected Shutdown
IT WAS REPORTED THAT THE DEVICE LOST IMAGE AND POWERED OFF DURING A PROCEDURE. THE USERS WERE UNABLE TO GET THE DEVICE TO POWER BACK ON, WHICH RESULTED IN A 15 MINUTE DELAY WHILE A REPLACEMENT WAS BROUGHT IN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WAS NO REPORT OF ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15252529 ↗MalfunctionJul 6, 2022Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT DURING A PROCEDURE THE IMAGE QUALITY WAS CLOUDY/GRAINY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE CASE, RESULTING IN A 1-2 MINUTE DELAY WHILE CONNECTING THE REPLACEMENT. THERE WAS A PATIENT INVOLVED; HOWEVER, THEY DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14940367 ↗MalfunctionMay 25, 2022Use of Device Problem; Temperature Problem
IT WAS REPORTED THAT THE HANDHELD DEVICE WAS LEFT ON A PATIENT IN ERROR. AS A RESULT, THE LIGHT FROM THE VIDEO PROCESSOR ILLUMINATOR CAUSED A SMALL HOLE TO BE BURNED INTO THE PATIENT DRAPE. THERE WAS NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14496622 ↗MalfunctionMar 8, 2022Poor Quality Image; Optical Problem; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE. PLEASE NOTE THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13688717 ↗
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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