RecallRadar

FDA Device recall Z-1414-2018

IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce…

On 2018-04-25 the FDA classified a Class II recall of IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce… by Philips Medical Systems Cleveland, citing closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1414-2018
ClassificationClass II
Statusterminated
Initiated2018-02-08
Published2018-04-25
Last updated2026-09-13 11:54 UTC
CompanyPhilips Medical Systems Cleveland
DistributionUS

Product

IQon Spectral CT - Model no. 728332, Computed Tomography X-Ray system Product Usage: 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 analysts and display equipment, patient and equipment supports, components, and accessories.

Reason

Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.

Identifiers

code_info
Serial no: 860023 860035 860047 860059 860010 860014 860015 860013 860029 860006 860002 860061 860011 8600…Serial no: 860023 860035 860047 860059 860010 860014 860015 860013 860029 860006 860002 860061 860011 860020 860024 860008 860039 860043 860018 860012 860022 860032 860033 860040 860009 860016 860017 860042 860003 860005 860037 860041 860025 860038 860036 860052 860056 860021 860053 860019 860054 860044 860028 860030 860026 860031 860034

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-1414-2018%22

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