Z-2404-2012Class III

The Brilliance CT 16 System

Name: Z-2404-2012 The Brilliance CT 16 System
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-08-28
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-08-28 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the... on 2012-08-28. FDA classified it as Class III and gives the reason as "Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button". 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-2404-2012
Classification: Class III
Status: Terminated
Initiated: 2012-08-28
Posted: 2012-09-19
Terminated: 2013-12-24
Recalling firm: Philips North America LLC
Product: The Brilliance CT 16 System Product Usage: The Brilliance 16 is a Whole Body Computed Tomography X-ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips was notified that the system logout in software version 2.3.6 is now longer and may sometimes fail to logout, requiring a forced system restart or hard shutdown with the power button.
Root cause tag: software
FDA root cause: Software change control
Action: Philips sent an Urgent - Medical Device Correction letter dated August 24, 2012 via certified mail to all US consignees. Philips Key Market representatives distributed the letter internationally. The letter identified the affected product, problem and actions to be taken by customer/user. Philips is implementing a software update to correct the issue free of charge. A Philips representative will contact affect sites to schedule the software installation. For further information or support contact your Philips representative or local Philips Healthcare office.
Quantity in commerce: 93 units
Distribution: Worldwide Distribution - US Nationwide including the states of: AL, CA, GA, MA, MD, NC, OH, PA, TX, and WA; and to the following countries of: Algeria, Oman, Australia, Brazil, China, Saudi Arabia, United Arab Emirates, and India.
Product codes and lots: System Code #, 728246, Serial #, 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2404-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2404-2012	Class III	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-18

Product code JAK

K012009Class IIMx8000 Idt CT SystemMarconi Medical Systems, Inc. / cleared 2001-09-13

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)