Visum Blade P22310Recalls & reported problems
Stryker Communications Inc. · Surgical Light Head Assembly, 5 Pole · Class 2
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 07613327061178), received between Feb 28, 2025 and Aug 15, 2025 — 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
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE OR 1 LIGHT HEAD DETACHED FROM THE SUSPENSION. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22819395 ↗MalfunctionFeb 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE OR9 LIGHT HEADS IS NOT WORKING AND IS DISCONNECTED. ONE LIGHT HEAD WAS COMPLETELY DISCONNECTED FROM THE CARDANIC ARM LEAVING THE CABLES EXPOSED. THERE WERE NO REPORTED INJURIES OR ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21496090 ↗
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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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