• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance 64, Brilliance Big Bore, Brilliance iCT, Brilliance iCT SP, Ingenuity CT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Brilliance 64, Brilliance Big Bore, Brilliance iCT, Brilliance iCT SP, Ingenuity CT
see related information
Date Posted January 24, 2012
Recall Status1 Terminated on June 18, 2013
Recall Number Z-0845-2012
Recall Event ID 60873
Premarket Notification
510(K) Numbers
K033326  K033357  K060937 
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Computed Tomography X-Ray Systems (Brilliance 64, Model Number: 728231; Brilliance Big Bore, Model Number: 728243; Brilliance iCT, Model Number: 728306; Brilliance iCT SP, Model Number: 728311; and Ingenuity CT, Model Number: 728326); Mfr. by Philips Medical Systems; Cleveland, OH. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Code Information Model #'s - Brilliance 64: 728231, Ingenuity CT: 728326, iCT: 728306; iCT SP: 728311 & Brilliance Big Bore: 728243
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The Common Image Reconstruction System (CIRS) on the affected Brilliance Systems encounters an error and requires reboot of the system. The unit failed to initialize axial scan due to timeout that occurred waiting for "READY" state
FDA Determined
Cause 2
DESIGN: Software Design
Action On 10/10/2011 the firm sent Urgent - Medical Device Correction letters to their customers. The letters identified the affected products, the problem, the hazard involved, the action to be taken by the customer, and actions planned by Philips. Customers were to reboot their systems if the two possible scenarios occurred. Philips Healthcare plans on installing the update through a Field Change Order free of charge. For further information or support concerning the issue, contact a local Philips representative or local Philips Healthcare office. In North America and Canada, contact Customer Care Solutions Center at 1-800-722-9377, option 5.
Quantity in Commerce 548 units
Distribution Worldwide Distribution -- USA, including the states of: AL, AZ, CA, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NM, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA & WV and the countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BANGLADESH, BELGIUM, Brazil, CHINA, COLUMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, HUNGARY, ICELAND, INDIA, INDONESIA, IRAQ, ISRAEL, ITALY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, LUXEMBOURG, MALAYSIA, MALI, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, PHILIPPINES, POLAND, QATAR, RUSSIA, SINGAPORE, SLOVENIA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, THAILAND, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN & VIETNAM.
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.
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS, INC.
-
-