AIM (Advanced Imaging Modality)Recalls & reported problems across all models
Stryker Corporation · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 59
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 4 models of AIM (Advanced Imaging Modality) by Stryker Corporation in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Jun 3, 2019 and Sep 23, 2026 — classified as 59 malfunctions.
The most frequently reported specific device problem is “Poor Quality Image” (28 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 AIM (Advanced Imaging Modality) problems
Device problems
- Poor Quality Image28
- Optical Problem19
- Fogging16
- Optical Obstruction5
- Optical Distortion4
- Break3
- Misfocusing3
- Moisture or Humidity Problem3
Patient problems
- No Clinical Signs, Symptoms or Conditions55
- Insufficient Information15
- No Known Impact Or Consequence To Patient7
AIM (Advanced Imaging Modality) models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- AIM (Advanced Imaging Modality) 0502537030Confocal optical imaging24 reports
- AIM (Advanced Imaging Modality) 0502937030Confocal optical imaging22 reports
- AIM (Advanced Imaging Modality) 0502937010Confocal optical imaging9 reports
- AIM (Advanced Imaging Modality) 0502537010Confocal optical imaging4 reports
Recent AIM (Advanced Imaging Modality) adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 23, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50876264 ↗MalfunctionAug 31, 2026Fogging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50531003 ↗MalfunctionAug 27, 2025Fogging; Moisture or Humidity Problem; Fogging; Moisture or Humidity Problem
IT WAS REPORTED THAT FOGGING WAS NOTICED DURING THE SURGICAL PROCEDURE. INITIALLY, AFTER INSERTION INTO THE PERITONEAL CAVITY, VISUALIZATION WAS NORMAL. DESPITE OUR ATTEMPTS, WE WERE UNABLE TO IMPROVE THE IMAGE QUALITY. AFTER REPLACING THE OPTICS, THE IMAGE RETURNED TO NORMAL. THE PATIENT WAS A 66-YEAR-OLD FEMALE WEIGHING 66 KG.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22904944 ↗MalfunctionApr 22, 2025Fogging; Optical Distortion; Fogging; Optical Distortion
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882336 ↗MalfunctionNov 15, 2024Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE DEVICE BROKE DURING PROCEDURE. THE BROKEN PIECE WAS SUCCESSFULLY REMOVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20696048 ↗MalfunctionApr 10, 2024Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19084904 ↗MalfunctionJan 17, 2024Fogging; Moisture or Humidity Problem; Fogging; Moisture or Humidity Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18531054 ↗MalfunctionJan 17, 2024Fogging; Moisture or Humidity Problem; Fogging; Moisture or Humidity Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18530888 ↗MalfunctionJan 9, 2024Fogging; Optical Problem; Fogging; Optical Problem
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18480554 ↗MalfunctionDec 21, 2023Poor Quality Image; Optical Problem; Poor Quality Image; Optical Problem
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18380191 ↗MalfunctionNov 22, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18195518 ↗MalfunctionNov 17, 2023Fogging; Fogging
IT WAS REPORTED THAT THERE WAS FOGGY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18159081 ↗MalfunctionOct 19, 2023Temperature Problem; Temperature Problem
IT WAS REPORTED THAT THERE WAS A THERMAL EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17968221 ↗MalfunctionSep 13, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17738917 ↗MalfunctionSep 5, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17687316 ↗
Other Stryker Corporation products
- RemB7 models · 3,073 reports
- Prime Series21 models · 1,548 reports · 2 recalls
- TARGET114 models · 1,077 reports
- ProCuity17 models · 368 reports · 13 recalls
- Spetzler-Malis20 models · 7 reports · 19 recalls
- SYNCHRO 28 models · 313 reports · 9 recalls
- Neptune E-SEP19 models · 412 reports · 7 recalls
- StrykeFlow4 models · 552 reports · 4 recalls
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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