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U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology

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 Class 2 Recall
Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology
see related information
Date Posted January 21, 2014
Recall Status1 Open
Recall Number Z-0801-2014
Recall Event ID 67168
Premarket Notification
510(K) Number
K033357 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835. Model #728244; 7621, 7636, 7809 & 7844.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland, Ohio 44143-2131
For Additional Information Contact Mrs. Kumudini J. Carter
440-483-3032
Manufacturer Reason
for Recall
Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed.
FDA Determined
Cause 2
DESIGN: Software Design
Action On 12/4/2013 the firm sent Urgent Medical Device Corrections letters to their customers.
Quantity in Commerce 32 units
Distribution Worldwide Distribution-USA (nationwide) including the states of AK, MD, NH, NV, OH, and OR, and the countries of Australia, China, France, India, Indonesia, Italy, Korea, Mexico, Poland, Romania, Russia, Spain, Switzerland, Taiwan, Thailand & United Arab Emirates.
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 = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
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