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U.S. Department of Health and Human Services

Class 2 Device Recall Tumor Localization (Tumor LOC) software application

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  Class 2 Device Recall Tumor Localization (Tumor LOC) software application see related information
Date Initiated by Firm January 28, 2009
Date Posted July 13, 2009
Recall Status1 Terminated 3 on September 19, 2012
Recall Number Z-1542-2009
Recall Event ID 50824
510(K)Number K033326  K033357-BB  K012009-EBW  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product TumorLoc software for the Brilliance Big Bore (BB) and the CT Extended Brilliance Workstation (EBW), Model #4550 116 02431 (TumorLoc).

The BB is a CT X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.
Code Information Lot Numbers: 7001-7354 for BB; and 8222, 8270, 8709, 8838, 8841, 8862, 8986, 9014, 9019, 9127, 9166, 10331, 10348, 10364, 10402, 10705, 10827, 11002, 11047, 11055, 11096, 11362, 11588, and 11597, for EBW.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall		 A software error in the TumorLoc software was discovered upon receipt of a customer complaint. There is the potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
FDA Determined
Cause 2		 Software design
Action Philips Medical issued an 'URGENT -Medical Device Correction' document dated January 28, 2009. This notification informs consignees of the TumorLoc imaging issue, the inherent hazards involved should this problem occur, the circumstances under which this problem may occur and corrective actions which the user/customer should perform in the event that this problem is encountered. It also informs that user/customer that Philips will have their Service Engineers contact the customers within 6 months to install a TumorLoc upgrade. For further questions, contact the Phillips Customer Care Center at 1-800-722-9377.
Quantity in Commerce 356 units
Distribution Worldwide Distribution - US, Australia, Austria, Bahrain, Bangladesh, Belgium, Brazil, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Jordan, Libyan Arab Jamahiriya, Lithuania, Malaysia, Netherlands Antilles, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Tahiti, Taiwan, Thailand, United Kingdom and Venezuela.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
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