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U.S. Department of Health and Human Services

Class 2 Device Recall The Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners

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 Class 2 Device Recall The Brilliance 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scannerssee related information
Date Initiated by FirmMarch 21, 2013
Date PostedJune 25, 2013
Recall Status1 Terminated 3 on November 27, 2013
Recall NumberZ-1588-2013
Recall Event ID 65137
510(K)NumberK033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance CT 64, Ingenuity CT, Ingenuity Core, and Ingenuity Core128 scanners are whole body Computed Tomography X-ray systems. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission.
Code Information The following codes are affected by this recall:System Code #728231, Serial #: 9654, 91003, 95130, 95157, 95504  System Code #728326, Serial #:  32000,300003,300004,300005,300010,300011,300012,300013, 300014,300015,300018, 300027,300041,300053,300054, 300059, 300066, 300070,300071, 300073, 300074, 30077, 300078, 300079, 300080,300082,300084,300086,300091,300092, 300095, 300101, 300102,300112, 300119, 300127, 300128, 300129, 300131, 300132, 310064, 320030  System Code #728321, Serial #: 310096, 310070  System Code #728323, Serial #: 320033
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7600
Manufacturer Reason
for Recall		If the operator selects a patient name from the worklist using the mouse and then selects a different patient name using the keyboard (arrow keys then press enter) the patient name that populates the exam information page is the patient name selected with the mouse. Also, it is possible to begin a normal clinical scan while the anti-virus scan is running. However, if the user is running a bol
FDA Determined
Cause 2		Software design
ActionPhilips Medical Systems sent an "URGENT-MEDICAL DEVICE CORRECTION" letter dated Mar 21, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Additionally, a Field Service Engineer will contact each site to schedule a time to implement the Field Change Order.
Quantity in Commerce50 units
DistributionNationwide Distribution-including the states of AR, AZ, DE, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, and WY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JAK
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