Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. soft...
FDA Recall #Z-0400-2016 — Class II — April 25, 2006
Product 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 for Recall
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.
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Cleveland, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
54 units
Distribution
Worldwide distribution, including US states of CA and NV.
Code Information
Model # 728243 Software Version 2.0
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated