FDA recall Z-1602-2020

Product

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

Reason for recall

The firm has become aware that there is a likelihood that a missing snap ring or spanner nut may result in an insufficient mount force that causes the surgical light to fall. If the suspension of the surgical light falls, it may potentially cause serious injuries to Health Care Providers and/or patients.

Distribution

US: Nationwide OUS: Canada

Key facts

Status

Terminated

Initiation date

2019-10-11

Report date

2020-04-08

Termination date

2022-10-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Flower Mound, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1602-2020