Recall Z-0706-2017— Philips Medical Systems (Cleveland) Inc
Class II · Terminated
Class II FDA medical device recall by Philips Medical Systems (Cleveland) Inc, initiated 2016-11-14, terminated 2018-07-02. It names one FDA 510(k) clearance: K150665. 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: A software defect is causing issues with the IQon Spectral CT and Philips Spectral CT Applications while filming, saving and annotating images.
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-11-14
- Terminated
- 2018-07-02
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.