1588 AIM 1588010000Recalls & reported problems
Stryker Corporation · Camera Control Unit · Class 2
All models of 1588 AIM (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker 1588 AIM Camera Control Unit is the imaging control box used with confocal optical imaging equipment during surgery. The 34 reports mostly describe the screen going blank or the picture coming out dark, blurry or missing entirely, with a few cases of no output or power loss. One report describes a laceration and a superficial burn; there are no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 35
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 07613327174328), received between Jan 3, 2019 and Jun 26, 2026 — classified as 2 injuries, 33 malfunctions.
The most frequently reported specific device problem is “No Display/Image” (22 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- No Display/Image22
- Poor Quality Image7
- No Device Output3
- Electrical Power Problem2
- Erratic or Intermittent Display2
- Loss of Power2
- Output Problem2
- Activation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Known Impact Or Consequence To Patient7
- Insufficient Information4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Electric Shock1
- Laceration(s)1
- Superficial (First Degree) Burn1
Recent adverse event reports
The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2026No Display/Image
IT WAS REPORTED THAT THE VIEW ON THE CAMERA WAS NOT STARTING. WHEN THE DECISION TO CANCEL THE MEDICAL PROCEDURE WAS MADE, THE PATIENT HAD ALREADY RECEIVED ANESTHESIA AND INCISIONS HAD ALREADY BEEN MADE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25640873 ↗MalfunctionSep 19, 2024No Display/Image; No Device Output; No Display/Image; No Device Output
IT WAS REPORTED THAT THERE WAS LOSS IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20260645 ↗MalfunctionMay 10, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS DARK OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19293330 ↗MalfunctionApr 11, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS DARK OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19091761 ↗MalfunctionApr 3, 2024No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19038151 ↗MalfunctionMar 8, 2024Poor Quality Image; Output Problem; Poor Quality Image; Output Problem
IT WAS REPORTED THAT THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870759 ↗MalfunctionMar 8, 2024No Device Output; No Device Output
IT WAS REPORTED THAT THERE WAS FULL LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18870648 ↗MalfunctionMar 6, 2024No Display/Image; No Device Output; No Display/Image; No Device Output
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18852907 ↗MalfunctionJan 25, 2024Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS BLURRY IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18584715 ↗MalfunctionNov 16, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18152659 ↗MalfunctionNov 16, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18152658 ↗MalfunctionOct 19, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17967793 ↗MalfunctionOct 19, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17967777 ↗MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17560767 ↗MalfunctionAug 16, 2023Poor Quality Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS POOR IMAGE QUALITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17560637 ↗MalfunctionAug 7, 2023No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17476577 ↗MalfunctionJun 29, 2023Electrical Power Problem; Electrical Power Problem
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17231725 ↗MalfunctionDec 15, 2022No Display/Image; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15988319 ↗InjuryAug 18, 2022Erratic or Intermittent Display; No Display/Image; Erratic or Intermittent Display
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE AND THE THE PROCEDURE WAS CONVERTED TO AN OPEN PROCEDURE.
Patient problems: Laceration(s); No Clinical Signs, Symptoms or Conditions
MAUDE report 15252196 ↗MalfunctionJun 1, 2022Inappropriate/Inadequate Shock/Stimulation; Electrostatic Discharge; Electrostatic Discharge
IT WAS REPORTED THAT THERE WAS ELECTRICAL SHOCK TO THE USER. THE USER WAS NOT INJURED.
Patient problems: Electric Shock; No Clinical Signs, Symptoms or Conditions
MAUDE report 14569265 ↗MalfunctionApr 7, 2022Intermittent Continuity; Intermittent Continuity; No Display/Image
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14044426 ↗MalfunctionDec 30, 2021No Display/Image; Optical Distortion; Optical Distortion
IT WAS REPORTED THAT THERE WAS LOSS OF VISUALIZATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13120252 ↗MalfunctionAug 19, 2021No Display/Image; Poor Quality Image; No Display/Image; Poor Quality Image
IT WAS REPORTED THAT THERE WAS LOSS OF VISUALIZATION.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12345476 ↗MalfunctionAug 3, 2021No Display/Image; Intermittent Loss of Power; Intermittent Loss of Power
IT WAS REPORTED THAT THERE WAS LOSS OF IMAGE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12269403 ↗MalfunctionJun 10, 2021Output Problem; Output Problem; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE CASE WAS CANCELED AFTER THE PATIENT WAS PREPPED AND UNDER ANESTHESIA.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 11978006 ↗
Other Confocal optical imaging devices
- HD 3CMOS AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S200-XZ-EAOlympus Medical Systems Corp. · Confocal Optical Imaging1,110 reports
- VISERA ELITE II VIDEO SYSTEM CENTER OLYMPUS OTV-S200Olympus Medical Systems Corp. · Confocal Optical Imaging870 reports
- HD 3CMOS CAMERA HEAD OLYMPUS CH-S200-XZ-EBOlympus Medical Systems Corp. · Confocal Optical Imaging698 reports
- L11 0220230300Stryker Corporation · Confocal optical imaging233 reports
- L10 0220220300Stryker Corporation · Confocal optical imaging77 reports
- AIM SafeLight 0233050300Stryker Corporation · Confocal optical imaging62 reports
- SafeLight 0233050400Stryker Corporation · Confocal optical imaging56 reports
- 1588 AIM 1588020122Stryker Corporation · Confocal optical imaging26 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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