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Recall Observatory FDA recall evidence

Device product

Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.

Z-0692-2018

January 26, 2018

Class II

Product summary

Firm
Stryker Communications
Event
Event 79116
Status
Terminated
Classification
Class II
Quantity
850
Official record key
device-enforcement:Z-0692-2018

Official wording

Reason: The mounts on the monitor may have an insufficient (missing or incomplete) weld.

Code information: United States and Canada: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230; International: Serial numbers 6145060-O11628 to 6176090-V14102

Distribution pattern: Distribution was made to medical facilities nationwide, including government and military distribution. Foreign distribution was made to Canada, Belgium, China, United Kingdom, UAE, France, Germany, Spain, Japan, Ecuador, and Russia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The mounts on the monitor may have an insufficient (missing or incomplete) weld.