Z-0675-2013Class II

Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland...

Name: Z-0675-2013 Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland...
Creator: Philips Medical Systems (Cleveland) Inc
Published: 2012-09-11
License: https://open.fda.gov/license/

Philips North America LLC / initiated 2012-09-11 / Terminated / root cause: software

FDA source

Philips Medical Systems (Cleveland) Inc began a recall of Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a... on 2012-09-11. FDA classified it as Class II and gives the reason as "Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However...". 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-0675-2013
Classification: Class II
Status: Terminated
Initiated: 2012-09-11
Posted: 2013-01-16
Terminated: 2014-02-14
Recalling firm: Philips North America LLC
Product: Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace Portal is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. The portal (together with the scanner) provides image processing and display through software applications that process, analyze, display, quantify and interpret medical images/data.
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: Philips was notified that when performing post processing with the Brilliance Workspace Portal platform with software versions 2.6.1.4, the coronary arteries in the rendered image are segmented automatically. However, the center line is not extracted or highlighted upon hovering and making it impossible to activate the vessel and choose the appropriate name (label) from the drop-down menu.
Root cause tag: software
FDA root cause: Software design
Action: Philips Healthcare sent a "CUSTOMER INFORMATION -URGENT-MEDICAL DEVICE CORRECTION" letter dated September 13, 2012. The letter identified the product, problem, and actions to be taken by the customers. Philips Service Engineers will contact customers for implementation of the software update. Contact your local Philips representative or local Philips office for further information concerning this notice.
Quantity in commerce: 108 units
Distribution: Worldwide Distribution-USA including the states of AZ, CA, CO, IL, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA and WI and the countries of Austria, Canada, China, France, India, Ireland, Italy, Japan, Netherlands, Norway, Spain, Switzerland, Thailand and United Kingdom.
Product codes and lots: Model #728269; Serial #s: 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 80110, 80121, 80155, 80167, 80168, 80169, 80174, 80192, 80193, 80195, 80201, 80208, 80209, 80219, 80227, 80228, 80230, 80252, 80258, 80266, 80280, 80289, 80293, 80294, 80315, 80322, 80328, 80333, 80340, 80341, 80348, 80360, 80375, 80385, 80387, 80394, 80398, 80416, 80421, 80422, 80429, 80447, 80451, 80460, 80474, 80482, 80484, 80485, 80492, 80497, 80505, 80516, 80578, 80585, 80591, 80629, 80646, 80658, 80681, 80704, 80709, 80711, 80720, 80723, 80743, 80749, 80751, 80831, 80835, 80866, 80878, 80908, 80909, 80911, 80914, 80916, 80930, 80931, 80944, 80974, 80992, 80999, 81023, 81025, 81034, 81045, 81071, 81099, 81101, 81107, 81117, 81126, 81136, 95382 & 95592.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0675-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0675-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-23	2013-01-15

Product code JAK

K961464Class IISelect/spElscint, Inc. / cleared 1996-07-03

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)