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U.S. Department of Health and Human Services

Class 2 Device Recall MX8000 IDT CT SYSTEM

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 Class 2 Recall
MX8000 IDT CT SYSTEM
see related information
Date Posted July 06, 2009
Recall Status1 Open
Recall Number Z-1568-2009
Recall Event ID 52047
Premarket Notification
510(K) Number
K012009 
Product Classification System, Tomography, Computed, Emission - Product Code KPS
Product Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1. Model #455011202691 for Computed Tomography (CT); Model #455011002031 for Nuclear Medicine (NM). The "Extended Brilliance Workspace (EBW)" Dental Application v4.0 and v4.0.1 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.
Code Information Computed Tomography (CT) Model #455011202691, Serial Number: 5754, 6437, 6467, 6543, 6835, 7253, 7576, 7579, 7639, 8756, 8757, 10102, 10103, 10108, 10109, 10111-10114, 10116, 10117, 10119, 10120, 10122-10126, 10128, 10129, 10132, 10134-10144, 10146, 10151, 10154, 10158, 10161, 10163, 10167, 10173, 10174, 10175, 10179-10184, 10195, 10322, 10356, 10361, 10427, 10437, 10449, 10456, 10484, 10492, 10537, 10598, 10604, 10668, 10690, 10722, 10745, 10770, 10778, 10821, 10822, 10841, 10889, 10906, 10938, 10939, 10940, 10943, 10945, 10952, 10965, 10998, 11025, 11037, 11054, 11065, 11085, 11089, 11099, 11102, 11103, 11104, 11113, 11121, 11127, 11140, 11148, 11149, 11151, 11152, 11168, 11169, 11174, 11229, 11230, 11232, 11260, 11274, 11280, 11282, 11291, 11314, 11339, 11341, 11557, 11564, 11577, 11585, 11610, 11620, 11630, 11631, 11633, 11663, 11667, 11668, 11708, 11742, 11744, 11745, 11751, 11752, 11754, 11758, 11766, 11780, 11783, 11787, 11790, 11792, 11795, 11797, 11803, 11804, 11807, 11809, 11810, 11812, 11813, 11832, 11834, 11838, 11839, 11841, 11844, 11846, 11848, 11850, 11852, 11853, 11854, 11855, 11858, 11859, 11862, 11863, 11864, 11865, 11870, 11872, 11877, 11879, 11884, 11886, 11888, 11892, 11897, 11921, 11922, 11928, 11937, 11981-12064, 12071, 12073-12099, 12105, 12109, 12138, 12139, 12140, 12144, 12146, 12149, 12152, 12156, 12164, 12166, 12168, 12179, 12201, 12203, 12250-12259, 12272, 12276-12299, and 12450-12453. Nuclear Medicine (NM) Model #455011002031, Serial Number: 4123, 7003, 7004, 7005, 7013, 7016, 7052, 7061, 7066, 7145, 7060, 7050, 7011, and 7020.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
For Additional Information Contact Eileen Campbell
440-483-2200
Manufacturer Reason
for Recall
Philips Healthcare has decided to recall the Dental Application on the Extended Brilliance Workspace v4.0 and v4.0.1 due to the fact that when images are saved or filmed that contain the Curved Multi-planar Reformation Section (cMPRS) views that were created with a short curve the Right/Left annotations will be reversed.
FDA Determined
Cause 2
DESIGN: Software Design
Action An "URGENT - Field Safety Notice" dated April 27, 2009 was sent to all consignees via certified mail. The letter described the affected products, issue, and actions for the customer/user. The notification letter provides a work around until the new software is available. For further information or support concerning this issue, please contact your local Philips representative: Customer Care Center (1-800-722-9377, option 5: Diagnostic Imaging, option 5: Radiation Therapy, option 3: Oncology) or to your local Philips Healthcare office.
Quantity in Commerce 417 units
Distribution Worldwide Distribution -- US including DC (states of AL, AR, AZ, CO, DC, FL, IL, KY, LA, MA. ME, MI, MN, MO, NJ, NY, OH, OR, PA, SC, TN, TX, VT, and WI) and countries of Africa, Albania, Austria, Australia, Bangladesh, Belgium, Brazil, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Holland, India, Iraq, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Oman, Pakistan, Peru, Philippines, Poland, Puerto Rico, Russia, Singapore, Spain, South Africa, Sweden, Switzerland, Syria, Tahiti, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uzbekistan, and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = KPS and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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