FDA Device recall Z-0675-2013
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance W…
- FDA Device
- Class II
- terminated
- Published 2013-01-23
On 2013-01-23 the FDA classified a Class II recall of Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance W… by Philips Medical Systems Cleveland, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0675-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-11 |
| Published | 2013-01-23 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Philips Medical Systems Cleveland |
| Distribution | AZ, CA, CO, IL, IN, MA, ME, MI, MO, NC, NJ, NY, OR, TN, TX, VA, WI |
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.
Reason
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.
Identifiers
| code_info | Model #728269; Serial #s: 79906, 79921, 79927, 79937, 80007, 80026, 80031, 80040, 80058, 80062, 80066, 80069, 80087, 8…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0675-2013%22
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