Z-2446-2019 Class II Terminated
FDA device recall Z-2446-2019 was initiated by Stryker Communications on August 1, 2019 and is designated Class II. Reason for recall: The mounts on the monitor may have an insufficient weld. The recall status is terminated (terminated April 27, 2021). Affected quantity: 52 devices.
Recall Details
- Product Type
- Devices
- Report Date
- September 11, 2019
- Initiation Date
- August 1, 2019
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52 devices
Product Description
Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Reason for Recall
The mounts on the monitor may have an insufficient weld.
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.
Code Information
Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.