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U.S. Department of Health and Human Services

Class 2 Device Recall Berchtold Chromophare F628 Surgical Lights

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  Class 2 Device Recall Berchtold Chromophare F628 Surgical Lights see related information
Date Initiated by Firm March 22, 2019
Create Date September 12, 2019
Recall Status1 Open3, Classified
Recall Number Z-2540-2019
Recall Event ID 83355
Product Classification Light, surgical, ceiling mounted - Product Code FSY
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.
Code Information Serial number ranges: 83171-0017818 to 83171-0123938
Recalling Firm/
Manufacturer		 Stryker Communications
571 Silveron Blvd
Flower Mound TX 75028
For Additional Information Contact Ms. Jennifer S. Harris
469-470-4316
Manufacturer Reason
for Recall		 The back cover of the light head was insufficiently assembled and could potentially fall off the light.
FDA Determined
Cause 2		 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 3,344 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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