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Recall Observatory FDA recall evidence

Device product

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

Z-1602-2020

October 11, 2019

Class II

Product summary

Firm
Stryker Communications
Event
Event 85083
Status
Terminated
Classification
Class II
Quantity
1415 Surgical Lights
Official record key
device-enforcement:Z-1602-2020

Official wording

Reason: The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.

Code information: Serial Number Range: 091316 70016 through 083117-73252

Distribution pattern: US: Nationwide OUS: Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.