Data Foundry

Medical device recalls 2016

Philips Spectral CT Applications supports viewing and analysis of… — Class II medical device recall Z-0706-2017

Terminated recall by Philips Medical Systems (Cleveland) Inc, reported 2016-12-14, distributed in AR, IN, LA, MA, MN, OR, TN. A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filmi

Recall numberZ-0706-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmPhilips Medical Systems (Cleveland) Inc, Cleveland, OH, United States
Recall initiated2016-11-14
Classified2016-12-03
Reported by FDA2016-12-14
Terminated2018-07-02
DistributedAR, IN, LA, MA, MN, OR, TN
Countries outside the USBE, CH, DE, DK, FR, GB, JP, KR
Quantity20
Reason classessoftware

Product

Philips Spectral CT Applications supports viewing and analysis of images at energies selected from the available spectrum in order to provide information about the chemical composition of the body materials and/or contrast agents.

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0706-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.