Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Brilliance iCT SP XRay System

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


New Search Back to Search Results
 Class 2 Device Recall Brilliance iCT SP XRay Systemsee related information
Date Initiated by FirmJune 15, 2011
Date PostedSeptember 14, 2011
Recall Status1 Terminated 3 on February 22, 2013
Recall NumberZ-3209-2011
Recall Event ID 59681
510(K)NumberK060937 
Product Classification System, x-ray, tomography, computed - Product Code JAK
ProductBrilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy 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 Model #728311, Serial Numbers: 200005, 200013, and 200047.
Recalling Firm/
Manufacturer		 Philips Medical Systems (Cleveland) Inc
595 Miner Road
Cleveland OH 44143-2131
For Additional Information Contact
440-483-7000
Manufacturer Reason
for Recall		Software errors. Philips Medical's Field Service Engineers are installing software upgrades to certain of their Brilliance iCT and Brilliance ICT SP CT X-ray system units in order to correct non-conformances evidenced in these systems due to software errors.
FDA Determined
Cause 2		Other
ActionPhilips Medical ( Cleveland) Inc. indicated in the Correction and Removal Report dated June 21, 2011, that a Philips Field Service Engineer will be contacting each site in order to schedule a time to implement the Field Change Order. After which time, the Field Service Engineer will visit each customer site to install the software upgrade and the firm will be tracking the progress of this corrective action. For further questions please call (440) 483-7000.
Quantity in Commerce3 units
DistributionWorldwide Distribution -- USA (nationwide) including the states of DC, IL, IN, OH, PA and VT and the countries of Belgium and Israel.
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
-
-