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Recall Observatory FDA recall evidence

Device product

Berchtold Chromophare F628 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.

Z-2540-2019

March 22, 2019

Class II

Product summary

Firm
Stryker Communications
Event
Event 83355
Status
Ongoing
Classification
Class II
Quantity
3,344 lights
Official record key
device-enforcement:Z-2540-2019

Official wording

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

Code information: Serial number ranges: 83171-0017818 to 83171-0123938

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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