Computed Tomography X-Ray System Brilliance Workspace recall: Software Issue
Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace…
Why was Computed Tomography X-Ray System Brilliance Workspace recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, OH. The Brilliance Workspace…
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- Quantity
- 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.
- Recall date
- January 23, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)