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Terminated

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

FDA Recall Z-0692-2018 · Posted None

Recalling FirmStryker Communications
Recall StatusTerminated
Product CodeFSY
Date Initiated2018-01-26
Date Terminated2019-03-19
Product Quantity850

Reason for Recall

The mounts on the monitor may have an insufficient (missing or incomplete) weld.

Firm Action

The recalling firm issued letters dated 1/26/2018 via FedEx on 1/26/2018 explaining the issue and the potential adverse consequences.

Root Cause

Process control

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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