FDA recall Z-2446-2019

Product

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

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.

Key facts

Status

Terminated

Initiation date

2019-08-01

Report date

2019-09-11

Termination date

2021-04-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Flower Mound, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2446-2019