—#129680

Product

Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The products are intended to provide cross sectional images of the human body and visualization of the internal organs of the body.

FDA product code: JAK — System, X-Ray, Tomography, Computed
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K033357
Affected lot / code info: Model # 728243 Software Version 2.0

Why it was recalled

Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes information regarding relative locations of marked regions of interest on the patient work sheets to be incorrect and may cause mistreatment.

Root cause (FDA determination)

Software design

Action the firm took

Philips Medical Systems sent a product safety notice to customers and corrective software for the issue was released to the field on July 25, 2006. Service Reps will contact each customer to install the new version of software. For questions regarding this recall call 440-483-7600.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution, including US states of CA and NV.

Timeline

Recall initiated: 2006-04-25
Posted by FDA: 2015-12-10
Terminated: 2015-12-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129680. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.