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Recall Observatory FDA recall evidence

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

April 25, 2006

Class II

Product summary

Firm
Philips Medical Systems (Cleveland) Inc
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

    reason.device_software_design · v1.0.0

    anomaly was identified with software