Philips Medical Systems (Cleveland) Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Philips Medical Systems (Cleveland) Inc
Lot Codes / Batch Numbers
Model # 728243 Software Version 2.0
Products Sold
Model # 728243 Software Version 2.0
Philips Medical Systems (Cleveland) Inc is recalling Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. softwar due to Brilliance Big Bore- An anomaly was identified with software version 2.0 tumor localization application when printing work sheets. this causes inform. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, NV
Page updated: Jan 10, 2026