Stryker Communications: Medical Device Recall in 2019 - (Recall #: Z-2539-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 22, 2019

Date Posted: September 18, 2019

Recall Number: Z-2539-2019

Event ID: 83355

Reason for Recall:

The back cover of the light head was insufficiently assembled and could potentially fall off the light.

Status: Ongoing

Product Quantity: 946 lights

Code Information:

Serial number ranges: 83180-69712678 to 83180-88970377;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated