RecallRadar

FDA Device recall Z-0694-2017

Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of…

On 2016-12-14 the FDA classified a Class II recall of Brilliance 64 728232 Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of… by Philips Medical Systems Cleveland, citing software error due to the filament on timer.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0694-2017
ClassificationClass II
Statusterminated
Initiated2016-11-12
Published2016-12-14
Last updated2026-09-13 11:54 UTC
CompanyPhilips Medical Systems Cleveland
DistributionAK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY

Product

Brilliance 64 728232 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 may include signal analysis and display equipment, patient and equipment supports, components, and accessories

Reason

Software error due to the filament on timer

Identifiers

code_info122921, 123029, 123092, 123096, 123116, 123117, 123148, 123150, 123164, 123170, 123172, 123176, 123179, 123180, 123182, 123183, 123185 and 123191

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-0694-2017%22

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