Recall Z-2539-2019 ยท FSY Light, Surgical, Ceiling Mounted
Stryker Communications
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 accor
| Date | Mar 22, 2019 |
| Status | Open, Classified |
| Reason | The back cover of the light head was insufficiently assembled and could potentially fall off the light. |
| 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.