Z-1396-2018Class II

Brilliance 64 with 4.1.7 XX026 software version model number 728231

Name: Z-1396-2018 Brilliance 64 with 4.1.7 XX026 software version model number 728231
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2018-02-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2018-02-21 / Terminated

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images... on 2018-02-21. FDA classified it as Class II and gives the reason as "Surview scan with tube current lower than 30 mA is unable to be initialized". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1396-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-21
Posted: 2018-04-17
Terminated: 2020-04-10
Recalling firm: Philips North America LLC
Product: Brilliance 64 with 4.1.7 XX026 software version model number 728231 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 analysis and display equipment, patient and equipment supports, components, and accessories
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Surview scan with tube current lower than 30 mA is unable to be initialized.
FDA root cause: Under Investigation by firm
Action: On February 21, 2018 Philips Medical Systems sent a Customer Information Letter regarding the Philips Brilliance 64 Software Model 4.1.7. Customers were informed of how to identify affected products and instructed to use the Instructions For Use recommended 30mA for surview scans. Customers with questions or concerns should contact their local Philips representative or local Philips Healthcare office Customer Care Solutions Center at 1-800- 722-9377.
Quantity in commerce: 291
Distribution: Worldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
Product codes and lots: Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1396-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1396-2018	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)