Z-1410-2018Class II

Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system

Name: Z-1410-2018 Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-02-08
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-02-08 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance Big Bore (Oncology) - Model no. 728243, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce... on 2018-02-08. FDA classified it as Class II and gives the reason as "Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1410-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-08
Posted: 2018-04-17
Terminated: 2020-04-09
Recalling firm: Philips North America LLC
Product: Brilliance Big Bore (Oncology) - Model no. 728243, 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.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Closing the Emergency Stop may disable the horizontal motor, allowing the couch top to move during patient load or unload activities.
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm notified customers of the recall on February 8, 2018, via Urgent Field Safety Notice. The notice advised customers of the issue and affected products and lot numbers. Customers were advised that once the E-stop has been closed, the operator/technologist must initate a brief horizontal motion (in or out) using any of the operator control panels, CT-Box or tape/foot switches. This action will ensure the couch carbon top (upper pallet) is in a controlled state. Customers were informed that a Field Service Engineer would contact them to schedule site updates to correct the issue. Customers who need further information or support were advised to contact their local Philips representative. Additionally, they may contact the Customer Care Solutions Center (1-800-722-9377.
Quantity in commerce: 106
Distribution: Worldwide Distribution - U.S. Nationwide. International distribution to Canada, Mexico, Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cuba, Czech Republic, Denmark, Djibouti, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Ghana, Gibraltar, Greece, Guyana, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Republic of Korea, Laos, Lebanon, Lithuania, Macedonia, Malaysia, Maldives, Mali, Martinique, Monaco, Mongolia, Myanmar, Nepal, Netherlands, New Calcedonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Rwanda, Saint Pierre and Miquelon, Samoa, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan, Venezuela, and Vietnam.
Product codes and lots: Serial No: 75070 750002 75046 750002 75114 75118 75127 75130 750021 75128 750015 75052 75039 75027 75067 75041 75028 75036 75034 75029 75031 75047 75048 75057 75054 75049 75056 75053 75058 75062 75064 75066 75068 76023 75037 76022 76024 75104 75111 75126 75112 750006 76008 750014 75059 750005 75061 75107 750007 750008 75129 750013 75120 750028 750016 750022 750024 750025 750026 750029 75115 75131 750023 7524 75119 76002 75121 75108 75102 75101 75108 75100 750004 75132 750019 750020 75063 75044 750001 75113 750012 75035 75038 75051 75051 750010 750017 75055 75060 75055 750027 75105 75042 75032 75069 75040 75116 75065 75050 75065 76011 76010 76016 76020 76021 750018

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1410-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1404-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1405-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1406-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1407-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1408-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1409-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1410-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1411-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1412-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1413-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1414-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17
Z-1415-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-17

Product code JAK

K033357Class IIAcqsim-Multislice-CT, Model 453567042271Philips Medical Systems (Cleveland), Inc. / cleared 2004-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)