| Class 2 Device Recall Brilliance CT System, 16 Power configuration. | |
Date Initiated by Firm | March 11, 2005 |
Date Posted | August 30, 2005 |
Recall Status1 |
Terminated 3 on March 02, 2012 |
Recall Number | Z-1410-05 |
Recall Event ID |
32334 |
510(K)Number | K010817 |
Product Classification |
System, X-Ray, Tomography, Computed - Product Code JAK
|
Product | Brillance CT System, 16 Power configuration using version 1.2 or 1.2.1 software. |
Code Information |
All codes. |
Recalling Firm/ Manufacturer |
Philips Medical Systems (Cleveland) Inc 595 Miner Road Cleveland OH 44143-2131
|
For Additional Information Contact | George X. Kambic, Ph.D. 440-483-2557 |
Manufacturer Reason for Recall | When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect. |
FDA Determined Cause 2 | Other |
Action | The firm sent recall/field correction letters dated 3/11/05. |
Distribution | The devices were distributed to consignees throughout the United States and to consigness located in Argentina, Austria, Bahama, Belarus, Belguim, Brazil, Canada, China, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Ecuador, England, Finland, France, Greece, Germany, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Libya, Mexico, Morocco, Netherlands, New South Wales, New Zealand, Norway, Panama, Phillipines, Portugal, Poland, Romania, Russia, South Africa, Singapore, Slovenia, Spain, Sri Lanka, Switzerland, Sweden, Taiwan, Thailand, Turkey and Venezuela.
|
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
|
|
|
|