Stryker Communications recalls Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment

Recalled September 18, 2019 · FDA recall Z-2539-2019 · Stryker Communications

Hazard

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

Units

946 lights

Sold at

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.

Description

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

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.

Manufacturer(s)

Stryker Communications

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →