The Brilliance 64 and Ingenuity CT are Computed recall: Software Issue
The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer…
Why was The Brilliance 64 and Ingenuity CT are Computed recalled?
During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 Beta 2 software. When using the CIRS 4.0 Beta 2 software, during the recon during ready stage of reconstruction, images may be overlapped with, or superimposed on other images. Philips has disabled this feature at all sites evaluating 4.0 Beta 2 software. Philips will issue a software up
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?
91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157
- Product
- The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 6
- Distribution
- Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.
- Recall date
- September 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)