Computed Tomography X-Ray System Brilliance Workspace Portal, Model #728269 Philips Medical Systems, Highland Heights, O
FDA device recall Z-0675-2013 · posted 2013-01-16 · Terminated
Recall details
- Recalling firm
- Philips Medical Systems (Cleveland) Inc
- 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.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- JAK
- Quantity affected
- 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,
- Date initiated
- 2012-09-11
- Date posted
- 2013-01-16
- Date terminated
- 2014-02-14
- Location
- Cleveland, OH
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