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U.S. Department of Health and Human Services

Class 2 Device Recall Computed Tomography XRay System MX 8000 IDT 16

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 Class 2 Recall
Computed Tomography XRay System MX 8000 IDT 16
see related information
Date Posted October 22, 2010
Recall Status1 Terminated on September 21, 2012
Recall Number Z-0133-2011
Recall Event ID 56508
Premarket Notification
510(K) Number
K012009 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Computed Tomography X-Ray System MX 8000 IDT 16; Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056. Produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information Model # 728120; Serial #'s: 2513, 2518, 3147, 3217, 3014, 3050, 3068, 3188, 3091, 3051, 3099, 3126, 3183, 3303, 2539 & 3056.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Manufacturer Reason
for Recall
Philips Healthcare has decided to recall the Computed Tomography X-Ray System MX 8000 IDT due to the fact that the software upgrade for the MX 8000 IDT 16 v4.2.1 may not provide the optional collimation of 4x4.5 (18mm). If the customer does not verify the increment and thickness coincide with the newly selected collimation suggested by the conversion report, there is potential for a 6mm gap to ap
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Software Change Control
Action Philips Medical Systems (Cleveland), Inc. sent an URGENT - Field Safety Notice dated July 29, 2010 and August 23, 2010 to all customers. The notices identified the product, the problem, and the steps to be taken. Customers were instructed to locate and correct the error. Field Service Engineers were to visit each site to update the software For further information customers were to contact their local Philips Customer Care Center at 1-800-722-9377.
Quantity in Commerce 16 units
Distribution Product was sold in the following states: CA, DE, IN,OR, MA, NV, TN. Product was also sold in Canada and Australia
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 = JAK and Original Applicant = MARCONI MEDICAL SYSTEMS, INC.
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