Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2015 - (Recall #: Z-0400-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: April 25, 2006

Date Posted: December 16, 2015

Recall Number: Z-0400-2016

Event ID: 69121

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.

Status: Terminated

Product Quantity: 54 units

Code Information:

Model # 728243 Software Version 2.0

Distribution Pattern:

Worldwide distribution, including US states of CA and NV.

Voluntary or Mandated:

Voluntary: Firm initiated