Z-1411-2018Class II

Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system

Name: Z-1411-2018 Brilliance Big Bore (Radiology) - Model no. 728244, 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 (Radiology) - Model no. 728244, 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-1411-2018
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 (Radiology) - Model no. 728244, 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: 119
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: 76106 760012 760002 76075 75123 76034 76052 76088 76079 76007 76104 76082 76086 76077 76083 76013 76009 76034 76081 76014 76074 76030 76028 76054 76045 76047 76057 76068 76071 76069 76092 76073 760015 760006 760011 750003 75125 76004 76027 760008 760009 760020 76089 75033 75122 760014 760013 760004 76067 760007 75110 760017 760001 760005 760016 760019 760019 75043 760010 75030 75043 760018 75106 75117 75124 750011 76043 76062 76072 760003 76003 76018 76017 76005 76001 76078 76087 76019 76080 76090 76084 76006 76012 76015 76026 76036 76038 76037 76039 76035 76031 76033 76032 76107 76040 76042 76046 76041 76056 76055 76050 76044 76049 76053 76048 76051 76058 76061 76065 76063 76064 76060 76059 76066 76070 76076 76085 76091 76040

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1411-2018
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)