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.
Reported: September 18, 2019 Initiated: March 22, 2019 #Z-2539-2019
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.
Reason for Recall
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Details
- Recalling Firm
- Stryker Communications
- Units Affected
- 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, Kuwait, Lithuania, Mexico, Netherlands, Philippines, Poland, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
- Location
- Flower Mound, TX
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Stryker Communications. Units affected: 946 lights.
Why was this product recalled? ▼
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 18, 2019. Severity: Moderate. Recall number: Z-2539-2019.
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