Device 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.
Z-0400-2016
Product summary
- Event
- Event 69121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54 units
- Official record key
device-enforcement:Z-0400-2016
Official wording
Reason: 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.
Code information: Model # 728243 Software Version 2.0
Distribution pattern: Worldwide distribution, including US states of CA and NV.
Derived failure modes
-
Device software or design
anomaly was identified with software