Z-1588-2013Class II

Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed...

Name: Z-1588-2013 Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2013-03-21
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2013-03-21 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images... on 2013-03-21. FDA classified it as Class II and gives the reason as "If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information...". 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-1588-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-21
Posted: 2013-06-25
Terminated: 2013-11-27
Recalling firm: Philips North America LLC
Product: Brilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol
Root cause tag: software
FDA root cause: Software design
Action: Philips Medical Systems sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated Mar 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
Quantity in commerce: 50 units
Distribution: Nationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
Product codes and lots: The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code #728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030 System Code #728321, Serial #: 310096, 310070 System Code #728323, Serial #: 320033

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1588-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1588-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-03	2013-06-25

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)