Date Initiated by Firm |
January 04, 2019 |
Create Date |
January 09, 2019 |
Recall Status1 |
Completed |
Recall Number |
Z-0706-2019 |
Recall Event ID |
81886 |
510(K)Number |
K182076
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
Elekta Unity |
Code Information |
Serial Numbers: 1536549, 1536549 |
Recalling Firm/ Manufacturer |
Elekta Limited Linac House Fleming Way Crawley United Kingdom
|
Manufacturer Reason for Recall |
In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The firm notified their consignees about the issue on 01/04/2019 and will install additional fixation. |
Quantity in Commerce |
2 units |
Distribution |
TX and WI, Germany, Denmark, Netherlands, United Kingdom |
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.
|
510(K) Database |
510(K)s with Product Code = IYE and Original Applicant = Elekta Limited
|