| Class 2 Device Recall Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology | |
Date Initiated by Firm | December 04, 2013 |
Date Posted | January 21, 2014 |
Recall Status1 |
Terminated 3 on July 01, 2015 |
Recall Number | Z-0801-2014 |
Recall Event ID |
67168 |
510(K)Number | K033357 |
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
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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 OH 44143-2131
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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 | 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 |
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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.
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510(K) Database | 510(K)s with Product Code = JAK
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