Chromophare CH00000001Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 07613327296167), received between Jun 19, 2018 and Aug 28, 2026 — classified as 6 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (12 reports).

3 FDA recall records name this device's identifier, 3 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, 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.

Recalls naming this device

1. Feb 23, 2026Open, Classified

   Surgical light assembly may not adequate support the weight of the ceiling cover.

   Z-1688-2026 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Jul 15, 2025Open, Classified

   Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.

   Z-2620-2025 · Root cause: Component change control · Recall details · FDA record ↗

3. Feb 8, 2024Open, Classified

   Due to insufficient mounting force the stability of surgical light system cannot be guaranteed.

   Z-1506-2024 · Root cause: Employee error · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2026Detachment of Device or Device Component

  It was reported that the cosmetic cover of the SLX surgical light system shifted downward.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50488632 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557886 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OPERATING ROOM WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OPERATING ROOM #5 AND IN OPERATING ROOM #8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557870 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557860 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557835 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557805 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557777 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557759 ↗
• MalfunctionMar 10, 2026Break; Crack

  (EVENT 1) AGGREGATED EVENTS: (B)(6) 2026: DEEP DIVE RESULT: OR (OPERATING ROOM) #1 BEING CLOSED FOR A WEEK FROM (B)(6) 2026 THROUGH (B)(6) 2026. DURING THE WEEK HTM (HEALTHCARE TECHNOLOGY MANAGEMENT) HAD ONLY OBSERVED TWO SMALL CRACKS ON THE SIDE BY THE HANDLE OF STRYKER SURGICAL BOOM LIGHT COVERS, HTM WAS OBSERVING THEM TWICE A DAY FOR THE WEEK WITH NO CHANGE WHEN I LAST CHECKED THEM ON FRIDAY (B)(6) 2026. WHEN HTM CHECKED THE LIGHT COVER ON TUESDAY MORNING AT 8AM THERE WERE ADDITIONAL CRACKS, PLS. SEE THE ATTACHED PICTURES THAT HTM TOOK ON FRIDAY AND THEN ONES HTM TOOK ON TUESDAY. OR WAS CLOSED X 1 WEEK FOR THIS EXPERIMENT WITH THE APPROVAL OF CHIEF OF SURGERY. HTM WAS TOLD NOBODY USED THE ROOM, EMS DID NOT CLEAN THE ROOM, SO THERE WAS NO OTHER HUMAN INTERACTION WITH THE LIGHTS OR EQUIPMENT IN THE ROOM. BASED ON OUR EXPERIMENT IT LEADS ME TO BELIEVE THAT THE PLASTIC IS EITHER NOT GOOD QUALITY, OR THE COVERS DO NOT FIT CORRECTLY CAUSING TOO MUCH STRESS AND THEN THE COVERS TO CRACK. (EVENT 2) (B)(6) 2026: NURSING OBSERVED IN OR#5 AND INOR#8 THERE ARE BROKEN LIGHT COVERS. THIS IS AFTER EMS HAS CHANGED TO THE STRYKER APPROVED CLEANING SOLUTIONS.HTM WENT TO INSPECT THE COVERS AND IN O

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24557727 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPOTTED THAT THE CEILING COVER FOR THE LIGHT/FP SUSPENSION ON PATIENT LEFT IN OR 7 HAS SLID DOWN AND THERE IS A GAP. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24436840 ↗
• MalfunctionMay 10, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT THE FLAT PANEL MONITOR IS ONLY HANGING ONTO THE ARM BY A FEW CABLES IN OR 4. IT IS BELIEVED THAT SOMETHING INTERNAL IN THE ARM IS DAMAGED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19291756 ↗
• MalfunctionMar 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT LIGHT 1 IN OR 7 HAS SEPARATED FROM THE SUSPENSION AND FALLEN TO THE GROUND. THE CONNECTION TO THE SPRING ARM STILL PRESENT ON THE SUSPENSION AND THE LC BEARING HAS BROKEN AND SLID OUT OF THE PROXIMAL END OF THE CARDANIC. THERE WAS ONE EMPLOYEE AND NO PATIENTS IN THE ROOM WHEN THIS HAPPENED. NO ONE WAS STRUCK BY THE FALLING LIGHT. PRIOR TO THIS EVENT THE LIGHT DID NOT HAVE CONTROL FROM THE CFWP, BUT WOULD TURN ON FROM THE LIGHT HEAD. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18899400 ↗
• InjuryFeb 1, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE LIGHT DRIFTED DOWN AND THE SURGEON WAS HIT IN HEAD WALKING INTO IT. THE SURGEON REQUIRED STITCHES.

  Patient problems: Head Injury

  MAUDE report 18625082 ↗
• MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE D660 LIGHT HEAD DISCONNECTED FROM ARM. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18196517 ↗
• MalfunctionSep 18, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT REPORT THE BLUE COVER AT THE TOP OF THE LIGHT CAME OFF. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17769930 ↗
• MalfunctionSep 1, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ONE OF THE OR LIGHTS CAME COMPLETELY OFF THE ARM. THE LIGHT FELL AFTER A CASE WHILE THE LIGHT WAS BEING CLEANED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17672983 ↗
• MalfunctionMay 11, 2023Material Separation; Material Separation

  IT WAS REPORTED BY A NURSE THAT A BLUE DOME COVER HAS FULLY SEPARATED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911687 ↗
• MalfunctionSep 15, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE LIGHT HEAD FELL OUT OF SPRING ARM AND CRACKED IN OR 3. IT WAS FURTHER REPORTED THE LIGHT HEAD HIT A USER RESULTING IN A SMALL CUT BUT DID NOT REQUIRE MEDICAL INTERVENTION.

  Patient problems: Pain

  MAUDE report 15432655 ↗
• MalfunctionJan 11, 2022Material Separation; Material Separation

  IT WAS REPORTED AN OR 9 BLUE DOME HAS COME OFF OF THE LIGHT HEAD. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233178 ↗
• MalfunctionDec 21, 2021Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  IT WAS REPORTED A D660 LIGHT ON AN NC SUSPENSION FELL IN OPERATING ROOM 17. THE CARDANIC SEPARATED FROM THE SPRING ARM AND STRUCK A NURSE IN THE SHOULDER AS IT FELL. THEY TURNED OFF THE POWER TO THE SUSPENSION AND CUT THE WIRES TO REMOVE IT FROM THE AREA. THE NURSE REPORTED ONLY BRUISING AT THE TIME AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Bruise/Contusion

  MAUDE report 13055979 ↗
• MalfunctionAug 31, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE OR 1 BLUE DOME COVER COMING OFF OF LIGHT HEAD. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12397980 ↗
• MalfunctionAug 31, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE BLUE DOME FELL OFF OF THE F-GEN LIGHT HEAD IN OR 1. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12397748 ↗
• MalfunctionAug 3, 2021Material Separation; Material Separation

  IT WAS REPORTED THE BLUE DOME FELL OFF OF THE F-GEN LIGHT HEAD IN OR 1. IT WAS FURTHER REPORTED THIS OCCURRED OUTSIDE OF A PROCEDURE AND NO PATIENT INVOLVEMENT. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12268431 ↗
• MalfunctionJun 30, 2021Material Separation; Material Separation

  IT WAS REPORTED THE LIGHT HEAD DOME COVERS IN CVOR W HAS POPPED OFF AND NEEDS TO BE REPLACED. IT WAS FURTHER REPORTED THE CORRECT LOCATION WAS CVOR X. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12092156 ↗
• MalfunctionJun 22, 2021Material Separation; Material Separation

  IT WAS REPORTED THE DOME COVER FELL OFF IN R&D 2. THERE WERE NO REPORTED INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12040484 ↗