FDA-Device2015-12-16Class II
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.
Philips Medical Systems (Cleveland) Inc
Hazard
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.
Sold states
Worldwide distribution, including US states of CA and NV.
Affected count
54 units
Manufactured in
595 Miner Rd, N/A, Cleveland, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0400-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief