Polaris 600 G16720Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04048675416562), received between Mar 24, 2021 and Apr 28, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Material Disintegration

  IT WAS REPORTED THAT BLACK PARTICLES WERE OBSERVED FALLING ONTO THE PATIENT'S SURGICAL SITE FROM THE JOINT BETWEEN THE SPRING ARM AND THE GIMBAL DURING SURGERY. NO HEALTH CONSEQUENCES FOR THE PATIENT WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25012419 ↗
• MalfunctionJun 24, 2025Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING THE PREPARATION OF THE OPERATION ROOM THE SPRING ARM WAS FOUND TO BE BROKEN AND DANGLING. IT WAS REPORTED THAT THERE WAS NO PATIENT IN THE ROOM TO THAT TIME. THERE WERE NO HEALTH CONSEQUENCES FOR THE MEDICAL STAFF REPORTED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22317703 ↗
• MalfunctionApr 10, 2025Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE SPRING ARM COVER OF THE POLARIS 600 BECAME FRACTURED AND DROPPED INTO THE STERILE ENVIRONMENT OF THE OPERATING THEATER. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21811880 ↗
• MalfunctionDec 17, 2024Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE DISPLAY ARM WAS FALLING APART AND HANGING BY ITS WIRES. NO PATIENT OR STAFF INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20949852 ↗
• MalfunctionDec 17, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE DISPLAY ARM WAS FALLING APART AND HANGING BY ITS WIRES. NO PATIENT OR STAFF INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20949851 ↗
• MalfunctionOct 15, 2024Disconnection; Detachment of Device or Device Component; Device Fell; Disconnection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT LAMP FLASHED A FEW TIMES IN THE MORNING. WHEN THE LAMP WAS MOVED UP, IT FELL DOWN. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT, OR THE STAFF REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20449709 ↗
• MalfunctionJul 16, 2024Disconnection; Detachment of Device or Device Component; Device Fell; Disconnection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE MONITOR HOLDING SYSTEM BECAME SEPARATED FROM THE SPRING ARM. THE MONITOR SYSTEM WAS STILL SUPPORTED BY THE WIRING AND DID NOT FALL TO THE GROUND. ADDITIONALLY, IT WAS REPORTED THAT SOMETHING WHITE FELL ON TO THE BLANKET DRAPED OVER THE PATIENT DURING THE CASE. REPORTEDLY, THE ORIGIN OF THE WHITE MATERIAL WAS UNCLEAR OR IF IT WAS RELATED TO THE MONITOR HOLDING SYSTEM. THERE WERE NO HEALTH CONSEQUENCES FOR THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19749315 ↗
• InjuryMay 16, 2024Self-Activation or Keying; Improper or Incorrect Procedure or Method; Self-Activation or Keying; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT, ON THE EVENING OF (B)(6) 2024, DURING A C-SECTION SURGERY IN THE OR, A NURSE BUMPED INTO A POLARIS LIGHT AND WAS INJURED IN THE HEAD. A FIRST NURSE WAS IN THE ROOM AND CLAIMED TO HAVE INITIALLY POSITIONED THE LIGHT IN A HIGH POSITION. THE SECOND NURSE, WHO WAS OUTSIDE OF THE OPERATING ROOM, THEN ENTERED THE ROOM AND BUMPED INTO THE LIGHT. SHE CLAIMS THAT THE POLARIS LIGHT MUST HAVE DRIFTED DOWNWARDS BEFORE SHE ENTERED THE ROOM. SHE WAS TRANSFERRED TO THE ER FOR ASSESSMENT AND WAS ADVISED BY THE DOCTOR TO STAY OFF WORK FOR ONE WEEK AND TO BE REASSESSED AFTERWARDS.MORE INFOS FROM THE HEALTH STATUS AND SURGICAL PROCEDURE ARE NOT AVAILABLE AT THE PRESENT TIME.

  Patient problems: Head Injury

  MAUDE report 19330511 ↗
• MalfunctionNov 16, 2023Positioning Failure; Structural Problem; Detachment of Device or Device Component; Material Split, Cut or Torn; Device Fell; Positioning Failure; Structural Problem; Detachment of Device or Device Component; Material Split, Cut or Torn; Device Fell

  IT WAS REPORTED THE LIGHT HEAD WAS LOOSE. THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO INDICATION OF THE LIGHT HANGING/DANGLING. IN CASE OF RECURRENCE A FALL OF THE SYSTEM AND A RISK FROM PARTS FALLING DOWN CANNOT BE COMPLETELY EXCLUDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18146278 ↗
• MalfunctionNov 7, 2022Flaked; Flaked

  IT WAS REPORTED THAT IN THE COURSE OF AN OPERATION, PAINT CHIPPED OFF THE LAMP SYSTEM ABOVE THE OPERATING FIELD. NO PATIENT INJURY WAS REPORTED. THE PAINT CHIPS DID NOT FALL INTO OR ONTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15741972 ↗
• MalfunctionOct 7, 2022Detachment of Device or Device Component; Device Fell; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT THE LIGHT WAS BEING WIPED DOWN AFTER A SURGERY HAD COMPLETED. DURING THE PROCESS THE LAMP CAME LOOSE FROM THE MOUNT AND WAS HANGING BY THE WIRES. NO PATIENT INVOLVEMENT REPORTED; NEITHER USER HEALTH CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15560294 ↗
• MalfunctionMar 24, 2021Disconnection; Detachment of Device or Device Component; Device Fell; Disconnection; Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED: "THE NEWLY INSTALLED OPERATING ROOM LIGHT SYSTEM WITH TWO LIGHTS FROM DRÄGER, TYPE: POLARIS 600, DETACHED WITH THE ENTIRE SUPPORTING STRUCTURE FROM THE COLUMN CONSTRUCTION MOUNTED ON THE CEILING IN SEPTEMBER 2020. THE TWO LIGHTS WITH THE ASSOCIATED SUPPORT ARMS WERE ONLY ATTACHED TO THEIR CABLING, WHICH AT THE SAME TIME PREVENTED THE ENTIRE CONSTRUCTION FROM FALLING ONTO THE OPERATING ROOM FLOOR. THE ENTIRE SUBSTRUCTURE OF THE OR LIGHTS COMPLETELY DETACHED FROM THE CEILING-MOUNTED SUPPORT TUBE/COLUMN AND SLID DOWN."

  Patient problems: Insufficient Information

  MAUDE report 11561381 ↗