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U.S. Department of Health and Human Services

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

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 Class 2 Device Recall Philips Healthcare Brilliance iCT SP Computed Tomography Xray systemsee related information
Date Initiated by FirmOctober 29, 2015
Date PostedDecember 24, 2015
Recall Status1 Terminated 3 on June 26, 2018
Recall NumberZ-0546-2016
Recall Event ID 72684
510(K)NumberK060937 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance iCT SP Computed Tomography X-ray system
Code Information Model No. 728311; S/N: 200047, 200051, 200067, 200074, 200098, 200127, 200200, 200202, 200203, 200204, 200206 & 200209.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactMr. 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
ActionOn 10/30/2015 the firm sent Customer Information letters to their Consignees.
Quantity in Commerce12 Units
DistributionWorldwide 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 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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