Philips North America Llc BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Brand
Philips North America Llc
Lot Codes / Batch Numbers
Serial Numbers: 100100, 100434
Products Sold
Serial Numbers: 100100, 100434
Philips North America Llc is recalling BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head due to Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Recommended Action
Per FDA guidance
Philips Regional Service Manager spoke to Customer on 13 April 2021, and advised them to stop use of the product until repair could be completed and followed communication by email. On 14-Apr-2021 component was replaced and system returned to service.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026