RecallRadar

FDA Device recall Z-0596-2017

Ingenuity Core 128 Computed Tomography X-ray system, Model 728323

On 2016-11-23 the FDA classified a Class III recall of Ingenuity Core 128 Computed Tomography X-ray system, Model 728323 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-0596-2017
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

Ingenuity Core 128 Computed Tomography X-ray system, Model 728323

Reason

The product label does not include the correct current rating.

Identifiers

code_info32012, 32057, 320202, 320207, 320227, 320232, 336011, 336034, 336076, 336100, 336129, 336133, 336142, 36145, 336163

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-0596-2017%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.