Z-2446-2019Class II

Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare...

Name: Z-2446-2019 Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare...
Creator: Stryker Communications
Published: 2019-08-01
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2019-08-01 / Terminated / root cause: manufacturing process

FDA source

Stryker Communications began a recall of Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System on 2019-08-01. FDA classified it as Class II and gives the reason as "The mounts on the monitor may have an insufficient weld". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2446-2019
Classification: Class II
Status: Terminated
Initiated: 2019-08-01
Posted: 2019-08-30
Terminated: 2021-04-27
Recalling firm: STRYKER Communications, Inc.
Product: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel, a component of Berchtold Chromophare Ceiling Mounted Surgical Light System.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The mounts on the monitor may have an insufficient weld.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The recalling letter issued letters on 8/1/2019 via Fed Ex.
Quantity in commerce: 52 devices
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.
Product codes and lots: Serial numbers DFP-075-0307-0001 to DFP-075-1014-0230.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2446-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2446-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-08-30

Product code FSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)