The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray… — Class II medical device recall Z-2664-2014

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2014-09-24. During a Field Test (a customer external evaluation period), the customer detected a problem in the CIRS 4.0 B

Recall number	`Z-2664-2014`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Philips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated	2011-09-01
Classified	2014-09-18
Reported by FDA	2014-09-24
Terminated	2015-07-01
Countries outside the US	AU, BE, CN, IL, SE
Quantity	6
Reason classes	software

Product

The Brilliance 64 and Ingenuity CT are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2664-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.