Berchtold Chromophare F528 Surgical Lights. Product recall
Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized…
Why was Berchtold Chromophare F528 Surgical Lights. Product recalled?
The back cover of the light head was insufficiently assembled and could potentially fall off the light.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial number ranges: 83180-69712678 to 83180-88970377;
- Product
- Berchtold Chromophare F528 Surgical Lights. Product Usage: The medical lights are for usage in hospital treatment rooms. They provide localized…
- Recalling firm
- Stryker Communications
- 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, Kuwait, Lithuania, Mexico, Netherlands, Philippines, Poland, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom, Uruguay, and Vietnam.
- Recall date
- September 18, 2019
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)