FDA Enforcement
Class II
Terminated
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: Z-0400-2016
·
Reported December 16, 2015
Enforcement
- Recall Number
- Z-0400-2016
- Event ID
- 69121
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Philips Medical Systems (Cleveland) Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 16, 2015
- Initiation Date
- April 25, 2006
- Classification Date
- December 10, 2015
- Termination Date
- December 15, 2015
- Address
- 595 Miner Rd, N/A, Cleveland, OH, 44143-2131, United States
Description
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.
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 Info
Model # 728243 Software Version 2.0
Distribution
Worldwide distribution, including US states of CA and NV.
Quantity
54 units