Z-2539-2019Class II

Berchtold Chromophare F528 Surgical Lights

Name: Z-2539-2019 Berchtold Chromophare F528 Surgical Lights
Creator: Stryker Communications
Published: 2019-03-22
License: https://open.fda.gov/license/

STRYKER Communications, Inc. / initiated 2019-03-22 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Communications began a recall of Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting... on 2019-03-22. FDA classified it as Class II and gives the reason as "The back cover of the light head was insufficiently assembled and could potentially fall off the light". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2539-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-03-22
Posted: 2019-09-12
Recalling firm: STRYKER Communications, Inc.
Product: Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized lighting focused on the patient s body for detecting and treating disease, injury, and disability. The surgical lights may only be used in rooms used for medical purposes that have been equipped in accordance with VDE 0100-710 or IEC 60364-7-10 in accordance with the regulations.
Product code: FSY Light, Surgical, Ceiling Mounted
Reason for recall: The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The recalling firm issued letters via FedEx on 3/22/2019 to their U.S. consignees. The recall letter identified the affected product, problem and actions to be taken. ,The letter instructs the customer to disseminate it within their organization and that a Stryker representative will begin replacements for customer facilities in January. For the replacement, the Stryker representative will perform an onsite rework of the light head cover. In the meantime, the lights can continue to remain in full use. A response form was enclosed for the customer to indicate they have read and understood the instructions. The form was to be returned via email. The recalling firm's representatives will contact the customer to schedule an inspection of their light and will track completion of the visits and inspections.
Quantity in commerce: 946 lights
Distribution: Distribution was nationwide, including to Puerto Rico. There was also government/military distribution. Foreign distribution was made to Argentina, Austria, Australia, Belgium, Bulgaria, Canada, China, Colombia, Denmark, France, Germany, Hong Kong, India, Indonesia, Italy, Japan, Kazakhstan, Korea, Kuwait, Lithuania, Mexico, Netherlands, Philippines, Poland, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
Product codes and lots: Serial number ranges: 83180-69712678 to 83180-88970377;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2539-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2539-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-09-18	2019-09-12
Z-2540-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-09-18	2019-09-12

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)