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Philips Medical Systems (Cleveland) Inc recalls Brilliance CT (computed tomography) scanners, Big Bore configuration, Model number 728243. software version 2.0 The pr
Recalled December 16, 2015 · FDA recall Z-0400-2016 · Philips Medical Systems (Cleveland)
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. · FDA Class II
Units
54 units
Sold at
Worldwide distribution, including US states of CA and NV.
Description
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.
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.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →