Chromophare F300 CE2863075Recalls & reported problems
Berchtold Holding GmbH · Berchtold Examination Light ? Ceiling Mounted · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327296198), received between Apr 23, 2019 and Mar 15, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Component Missing1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE F300 WAS HANGING BY A CABLE AND NEEDED RE-INSTALLED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18917794 ↗MalfunctionApr 23, 2019Component Missing; Detachment of Device or Device Component; Component Missing; Detachment of Device or Device Component
IT WAS REPORTED THAT IN ROOM 2016, THE F300 EXAM LIGHT WOULD NOT POWER ON. A STRYKER FIELD SERVICE TECHNICIAN (SFST) WAS DISPATCHED FOR INVESTIGATION. THE SFST ENTERED THE ROOM AND FOUND THAT THE SPRING ARM WAS UNSEATED FROM THE HORIZONTAL ARM. THERE WERE NO INJURIES OR ADVERSE CONSEQUENCES.
Patient problems: No Patient Involvement
MAUDE report 8541322 ↗
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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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