BRILLIANCE VOLUME system - A Computed Tomography X-Ray recall
BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
Why was BRILLIANCE VOLUME system - A Computed Tomography X-Ray recalled?
Cooling Unit (CLU) expelled out of a CT gantry of an iCT system may result in injury
What should I do if I have this product?
Review the official FDA enforcement record for current 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 Numbers: 100100, 100434
- Product
- BRILLIANCE VOLUME system - A Computed Tomography X-Ray System intended to produce images of the head and body. Model Number: 728306
- Recalling firm
- Philips North America Llc
- Quantity
- 2 units (1 US and 1 OUS)
- Distribution
- Worldwide distribution - US Nationwide distribution in the state of NV and the country of Japan.
- Recall date
- June 9, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)