BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
This recall has been terminated (originally issued April 13, 2021).
- Company
- Philips North America Llc
- Recall Initiated
- April 13, 2021
- Terminated
- September 23, 2022
- Recall Number
- Z-1774-2021
- Quantity
- 2 units (1 US and 1 OUS)
- Firm Location
- Cambridge, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
Distribution
Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
Lot / Code Info
Serial Numbers: 100100, 100434
Root Cause
Under Investigation by firm
Action Taken
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.
More recalls by Philips North America Llc
Spectral CT;
Product Code (REF): 728333;
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Brilliance iCT;
Product Code (REF): 728306;
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IQon Spectral CT;
Product Code (REF): 728332;
Feb 6, 2026