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U.S. Department of Health and Human Services

Class 2 Device Recall BRILLIANCE VOLUME

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 Class 2 Recall
BRILLIANCE VOLUME
see related information
Date Posted June 29, 2009
Recall Status1 Open
Recall Number Z-1582-2009
Recall Event ID 52214
Product Classification System, X-Ray, Tomography, Computed - Product Code JAK
Product Brilliance iCT software v2.5.0, Model 728306. The Brilliance iCT is packaged INA carton and the software is contained within the Brilliance CT scanner. The 'Brilliance iCT' is a Computed Tomography X-ray System intended to produce cross-section images of the body by computer reconstruction of x-ray transmission data taken at different Ganges and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code Information Serial Numbers: 100001-100063, 100065-100073 and 100075-100076.
Recalling Firm/
Manufacturer
Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland, Ohio 44143-2131
Consumer Instructions Should an emergency arise requiring you to activate the ERDU, verify the Emergency Run Down light illuminates and that the magnet does quench (a very loud noise will be audible) before entering the scan room without screening personnel and equipment. Notify the Hitachi Customer Service Department at (800) 800-4925 immediately should you initiate an Emergency Run Down.
For Additional Information Contact Unknown
440-483-7000
Manufacturer Reason
for Recall
Software anomaly. An artifact may appear in brain scans and brain perfusion studies, when using 80kV and a UA, UB, or UC filter with this CT scanning device.
Action An "URGENT - Field Safety Notice" dated December 22, 2009 was issued via certified mail to affected customers. The letter described the affected product, problem, hazards involved, and actions for customers to take. Philips will provide customers with a software update for all affected systems within next 6 months. The firm also sent a second notification in the form of an "URGENT -Medical Device Correction" report dated January 29, 2009 which contained information noted in the "URGENT - Field Safety Notice". Direct questions to your local Philips representative or Philips Customer Care Center (1-800-722-9377), option 5: Other Imaging Systems, option 1: CT or to your local Philips Healthcare office.
Quantity in Commerce 44
Distribution Worldwide Distribution -- US including DC (states of CA, GA, IL, IN, KY, NY, MD, MN, OH, OR, and MD), Germany, Greece, Israel, Italy, Japan, Netherlands, Norway, Russia, South Korea, Switzerland, Taiwan, Canada, and Thailand.
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
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