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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Healthcare Brilliance 64

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 Class 2 Device Recall Philips Healthcare Brilliance 64see related information
Date Initiated by FirmFebruary 21, 2018
Create DateApril 17, 2018
Recall Status1 Terminated 3 on April 10, 2020
Recall NumberZ-1396-2018
Recall Event ID 79759
510(K)NumberK033326 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance 64 with 4.1.7 XX026 software version model number 728231 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components, and accessories
Code Information Serial numbers: . 9134 9667 9738 9788 9923 10773 95263 95669
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Rd
Cleveland OH 44143-2131
For Additional Information ContactHolly Wright Lee
440-483-5777
Manufacturer Reason
for Recall		Surview scan with tube current lower than 30 mA is unable to be initialized.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn February 21, 2018 Philips Medical Systems sent a Customer Information Letter regarding the Philips Brilliance 64 Software Model 4.1.7. Customers were informed of how to identify affected products and instructed to use the Instructions For Use recommended 30mA for surview scans. Customers with questions or concerns should contact their local Philips representative or local Philips Healthcare office Customer Care Solutions Center at 1-800- 722-9377.
Quantity in Commerce291
DistributionWorldwide Distribution - US Nationwide in the states of GA, VA, MI, AZ, and the countries of Canada, Switzerland
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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