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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance iCT Computed Tomography Xray system

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  Class 2 Device Recall Philips Healthcare Brilliance iCT Computed Tomography Xray system see related information
Date Initiated by Firm October 29, 2015
Date Posted December 24, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall Number Z-0545-2016
Recall Event ID 72684
510(K)Number K060937  
Product Classification System, x-ray, tomography, computed - Product Code JAK
Product Brilliance iCT Computed Tomography X-ray system
Code Information Model No. 728306; S/N: 85015, 85021, 85028, 85034, 85036, 85039, 85042, 85047, 85051, 100030, 100038, 100040, 100051, 100054, 100058, 100065, 100072, 100093, 100094, 100099, 100101, 100140, 100144, 100162, 100181, 100190, 100214, 100217, 100228, 100236, 100244, 100278, 100421, 100462, 100472, 100613, 100616, 100624, 100627, 100628, 100632, 100639, 100640, 100641, 100644, 100647, 100651, 100654, 100655, 100659, 100660, 100662, 100667 & 100669.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information Contact Mr. Jonathan Lee
440-483-2997
Manufacturer Reason
for Recall		 Perfusion scan feature may not be available on machines running software versions 4.1.2, 4.1.3, and 4.1.4. Customers previously using the basic axial perfusion software (versions preceding 4.1.2) without buying the helical perfusion license key could not access the basic axial perfusion feature after upgrading to software version 4.1.2.
FDA Determined
Cause 2		 Software design
Action On 10/30/2015 the firm sent Customer Information letters to their Consignees.
Quantity in Commerce 51 Units
Distribution Worldwide distribution. US nationwide, Australia, Austria, Bangladesh, Belgium, Brazil, Cambodia, Canada, China, Egypt, France, Germany, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Korea, Lebanon, Libya, Lithuania, Malaysia, Martinique, Myanmar, Mexico, Mozambique, Netherlands, New Zealand, Norway, Palestine, Panama, Philippines, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, Spain, Sweden, Switzerland, Tanzania, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Uzbekistan & Vietnam.
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(CLEVELAND), INC.
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