RecallRadar

FDA Device recall Z-0598-2017

IQon Spectral CT Computed Tomography X-ray system, Model 728332

On 2016-11-23 the FDA classified a Class III recall of IQon Spectral CT Computed Tomography X-ray system, Model 728332 by Philips Medical Systems Cleveland, citing the product label does not include the correct current rating.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0598-2017
ClassificationClass III
Statusterminated
Initiated2016-10-13
Published2016-11-23
Last updated2026-09-13 11:54 UTC
CompanyPhilips Medical Systems Cleveland
DistributionAL, AZ, CO, GA, IN, KY, LA, MA, MN, NY, OH, OR, PA, SC, TN, TX, UT, VA

Product

IQon Spectral CT Computed Tomography X-ray system, Model 728332

Reason

The product label does not include the correct current rating.

Identifiers

code_info860005, 860006, 860010

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0598-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.