Brilliance 64 recall
Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer…
Why was Brilliance 64 recalled?
Philips has identified that the compensator within the X-ray tube collimator may fail, resulting in ring or smudge artifacts on images. The firm has identified systems that may be at risk for this failure due to the collimator compensator being past its lifetime expected usage.
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?
10011 95620 10436 95486 95391 95838 95807 95621 10521 10255 10006 10715 10275 10616
- Product
- Brilliance 64, 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 14
- Distribution
- Distributed only to China and UK.
- Recall date
- April 24, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)