The Recall Desk
HighFDA (Devices)·Z-0828-2018·Announced 2018-03-07

Stryker Berchtold Chromophare Surgical Light Recall for Missing Parts

Stryker is recalling 1,162 Berchtold Chromophare surgical lights because missing parts could cause the equipment to fall.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (falling equipment) where injury has not yet been reported, which aligns with the 'High' severity criteria.

Plain-English summary

Stryker Communications is recalling 1,162 Berchtold Chromophare Ceiling Mounted Surgical Light Systems (Catalog #CH13000000). These medical lights are used in hospital treatment rooms to provide localized lighting for detecting and treating disease, injury, and disability.

The recall is due to a potential defect where the device could have a missing spanner nut and snap ring. This issue could potentially result in the equipment falling. The affected devices were distributed nationwide in the United States and in Canada.

Hospitals and medical facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a device is affected, it should be removed from service and Stryker should be contacted for instructions on repair or replacement.

The recalled product

Product
Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000. Product Usage: Chromophare surgical lights are medical lights for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating dise
Affected units
1,162

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers distributed in the U.S.: 022817-71019
  • 22817-71033
  • 022817-71034
  • 022817-71035
  • 022817-71048
  • 022817-71049
  • 022817-71050
  • 022817-71051
  • 030817-71104 030817-71105
  • 030817-71106
  • 030817-71107
  • 030817-71108
  • 030817-71109
  • 030817-71110
  • 030817-71111
  • 030817-71114
  • 030817-71115
  • 030817-71116
  • 030817-71117
  • 030817-71120

Distribution

Distributed nationwide across the United States.