FDA recall Z-0692-2018

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 (missing or incomplete) weld.

Distribution

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.

Key facts

Status

Terminated

Initiation date

2018-01-26

Report date

2018-03-07

Termination date

2019-03-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Flower Mound, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0692-2018