—#81987

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.

FDA product code: KPS — System, Tomography, Computed, Emission
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K012009
Affected lot / code info: 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.

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Philips Medical Systems (Cleveland) Inc
Address: 595 Miner Road, Cleveland, Ohio 44143-2131

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2009-04-27
Posted by FDA: 2009-07-06
Terminated: 2012-09-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #81987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.