Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.

FDA Recall Z-2446-2019 · Posted 2019-08-30

Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeFSY
Date Initiated2019-08-01
Date Terminated2021-04-27
Product Quantity52 devices

Reason for Recall

The mounts on the monitor may have an insufficient weld.

Firm Action

The recalling letter issued letters on 8/1/2019 via Fed Ex.

Root Cause

Process control

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑