|
Class 2 Device Recall Brilliance iCT and iCT SP |
 |
Date Initiated by Firm |
December 09, 2013 |
Date Posted |
January 27, 2014 |
Recall Status1 |
Terminated 3 on May 29, 2014 |
Recall Number |
Z-0832-2014 |
Recall Event ID |
67306 |
510(K)Number |
K060937
|
Product Classification |
System, x-ray, tomography, computed - Product Code JAK
|
Product |
Brilliance iCT & Brilliance iCT SP Computed Tomography X-Ray Systems, Philips Healthcare, Cleveland, OH
The Brilliance iCT and iCT SP are whole body 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. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. |
Code Information |
Brilliance iCT: 728306, Serial #'s: 100018, 100040, 100411, 100503, 100506 Brilliance iCT SP: 728311, Serial #'s: 200047, 200121 |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Rd Cleveland OH 44143-2131
|
For Additional Information Contact |
Mrs. Kumudini J. Carter 440-483-3032
|
Manufacturer Reason for Recall |
Patient images exhibited ring artifacts.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm, Philips Healthcare, sent an "URGENT - Medical Device Correction" letter dated December 9, 2013 to their customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following to avoid the occurrence of these specific ring artifacts:
1. Disable Automatic Scan Time for all Exam Cards
2. Leave Automatic Scan Time on during planning and prior to clicking Go
to initiate the scan, click the acquisition series of the scan and disable
Automatic Scan Time, then proceed with the scan.
3. Disable Edit Before Final Recon (Reconstruction) for all Exam Cards
If a ring artifact is present, clinical judgment should be used by the
customer/user to determine if the images acquired in the dataset contain enough information to make a diagnosis.
Philips will be releasing a Field Change Order (FCO) to correct the issue with software version release 4.1.1.19261. In addition, a Philips Field Service Engineer will contact you to schedule the software installation at your site.
If you need any further information or support concerning this issue, please
contact your local Philips representative or local Philips Healthcare office. For
North America and Canada, contact the Customer Care Solutions Center (1-800-722-9377, Option 5: Enter Site ID or follow the prompts). |
Quantity in Commerce |
7 units |
Distribution |
Worldwide Distribution: US (nationwide) including states of: FL, IN, NY, OR and PA; and internationally to: Australia and Israel. |
Total Product Life Cycle |
TPLC 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) Database |
510(K)s with Product Code = JAK and Original Applicant = PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
|
|
|
|