Z-0950-2013Class II

Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole...

Name: Z-0950-2013 Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-02-15
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-02-15 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to... on 2013-02-15. FDA classified it as Class II and gives the reason as "This field change order is being released to update software and customer release notes to the affected installed base". 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-0950-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-15
Posted: 2013-03-14
Terminated: 2014-04-11
Recalling firm: Philips North America LLC
Product: Brilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body 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. This device 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: This field change order is being released to update software and customer release notes to the affected installed base.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent an Urgent Medical Device Correction letter dated February 13, 2013, via certified mail to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were advised to review the information contained in the letter with all members of their staff who need to be aware of the contents of the letter. Customers were instructed to retain a copy with the equipment Instruction for Use. For questions customers were instructed to contact their local Phillips representative or local Philips Healthcare office. For North Americal and Canada contact Customer Care Solutions Center at 1-800-722-9377, option 5: Enter Site ID or follow the prompts For questions regarding this recall call 1-800-722-9377.
Quantity in commerce: 42 Units
Distribution: Worldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.
Product codes and lots: Brilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0950-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0950-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-20	2013-03-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)