FDA recall Z-0841-2018

Philips Medical Systems (Cleveland) Inc · Class II · device

Product

IQon Spectral CT with 4.7.2 software version.- Model 728332, a Philips Computed Tomography X-Ray System

Reason for recall

23 Software related issues for the IQon Spectral CT with 4.7.2 software version. These issues include: " Software errors that may result in CT spectral images misrepresentation or incorrect treatment; " Software errors that may result in partial set of images or inability to generate CT images.

Distribution

Domestic and Foreign

Key facts

Status: Terminated
Initiation date: 2018-01-11
Report date: 2018-03-14
Termination date: 2019-05-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Cleveland, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0841-2018