Philips Medical Systems (Cleveland) Inc: Medical Device Recall in 2016 - (Recall #: Z-0705-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.

Product Classification:

Class II

Date Initiated: November 14, 2016

Date Posted: December 14, 2016

Recall Number: Z-0705-2017

Event ID: 75755

Reason for Recall:

A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images

Status: Terminated

Product Quantity: 24

Code Information:

860008 860009 860010 860011 860012 860013 860014 860015 860016 860017 860018 860019 860020 860021 860022 860023 860024 860028 860026 860029 860030 860031 860034 860035

Distribution Pattern:

Software was distributed in the following states: AR, IN, LA, MA, MN, OR and TN. Softward was also shipped to the following countries: Belgium, Denmark, France, Germany, Japan, Korea, Switzerland and United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated