Z-1602-2020Class II

Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000

Name: Z-1602-2020 Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Creator: Stryker Communications
Published: 2019-10-11
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2019-10-11 / Terminated

FDA source

Stryker Communications began a recall of Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000 on 2019-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1602-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-11
Posted: 2020-03-27
Terminated: 2022-10-18
Recalling firm: STRYKER Communications, Inc.
Product: Berchtold Chromophare Ceiling Mounted Surgical Light System, Catalog #CH13000000
Product code: FSY Light, Surgical, Ceiling Mounted
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.
FDA root cause: Other
Action: On October 11, 2019, a "Urgent Medical Device Correction" letter was sent to all affected customers via FedEx. In addition to explaining the recall, the recall letter as customers to take the following action: Please assure this notification letter is disseminated within your organization. A Stryker Representative will begin scheduling visits to customer facilities to perform inspections. This correction is expected to last one year. During the inspection, the Stryker Representative will perform a visual inspection on the lower portion of the Chromophare Ceiling Mounted Surgical Light Suspension. If a nonconforming unit is found, Stryker will replace the non-conforming Chromophare Ceiling Mounted Surgical Light Suspension with a new Chromophare Ceiling Mounted Surgical Light Suspension. In the meantime, the lights can continue to remain in full use. If you have any questions or notice any issues regarding this correction: " Stryker Technical Support at 866-841-5663 or [email protected] " Nicole Kubat, Senior RA Compliance Specialist at 469-470-4318 or [email protected] " E-mail: [email protected]
Quantity in commerce: 1415 Surgical Lights
Distribution: US: Nationwide OUS: Canada
Product codes and lots: Serial Number Range: 091316 70016 through 083117-73252

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1602-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1602-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-08	2020-03-27

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)