—#129396

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.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033326
Affected lot / code info: 91003, 30018, 95504, 300004, 300030, 300010, 95130, 95157

Why it was 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

Root cause (FDA determination)

Software design

Action the firm took

The firm, Philips, sent a Field Safety Notice (FSN 72800534) entitled "URGENT-Medical Device Correction" dated September 1, 2011 via mail on September 6, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to review the following information with all members of your staff who need to be aware of the contents of this communication and retain a copy with the equipment Instructions for Use. A Field Service Engineer will visit each site to install the corrected software. If you need any further information or support concerning this issue, please contact your local Philips representative or local Philips Healthcare office. For North America and Canada contact the Customer Care Solutions Center (1-800-722-9377, option 5: Enter Site ID or follow the prompts).

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Rd, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: Worldwide Distribution: US distribution in OH and countries of: Australia, China, Belgium, Israel, and Sweden.

Timeline

Recall initiated: 2011-09-01
Posted by FDA: 2014-09-18
Terminated: 2015-07-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129396. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.