FDA Enforcement
Class II
Terminated
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Recall: Z-1774-2021
·
Reported June 9, 2021
Enforcement
- Recall Number
- Z-1774-2021
- Event ID
- 87872
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips North America Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- June 9, 2021
- Initiation Date
- April 13, 2021
- Classification Date
- June 2, 2021
- Termination Date
- September 23, 2022
- Address
- 222 Jacobs St, Cambridge, MA, 02141-2289, United States
Description
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Reason
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Code Info
Serial Numbers: 100100, 100434
Distribution
Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Quantity
2 units (1 US and 1 OUS)