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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-2446-2019

August 01, 2019

Class II

Product summary

Firm
Stryker Communications
Event
Event 83510
Status
Terminated
Classification
Class II
Quantity
52 devices
Official record key
device-enforcement:Z-2446-2019

Official wording

Reason: The mounts on the monitor may have an insufficient weld.

Code information: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.

Distribution pattern: Distribution was made to CA, CO, CT, FL, GA, IL, IN, MD, MI, MN, MO, NC, NH, NJ, NY, OH, PA, SC, TN, TX, and WI. There was foreign distribution to Canada and Germany. There was no government/military distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The mounts on the monitor may have an insufficient weld.