[Recalled] The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Philips is issuing a software update (version 3.2.4) to the Brilliance iCT and iCT SP systems currently running software version 3.2.0, 3.2.1 or 3.2.3, addressing a number of non-conformances. A review was conducted of all nonconformances that are fixed by the software upgrade. None of these nonconformances result in unacceptable hazards. The nonconformance documented below had the highest sc

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Philips Medical Systems (Cleveland) Inc

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.