FDAFDA · Food and drugs·Recall number Z-2446-2019
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Published September 11, 2019 · Recall initiated: August 1, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The mounts on the monitor may have an insufficient weld.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Communications
- Distributor
- 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.
- Lot
- Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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