Z-1413-2018Class II

Brilliance 64 - Model no. 728231, Computed Tomography X-Ray system

Name: Z-1413-2018 Brilliance 64 - Model no. 728231, 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 64 - Model no. 728231, Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images... 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-1413-2018
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 64 - Model no. 728231, 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: 6
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: 9541 10207 9890 9633 10561 10655

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1413-2018
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

K033326Class IIPhilips Plus Computed Tomography SystemPhilips Medical Systems, Inc. / cleared 2003-10-29

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)