Date Initiated by Firm |
February 14, 2017 |
Create Date |
March 20, 2017 |
Recall Status1 |
Terminated 3 on December 18, 2017 |
Recall Number |
Z-1489-2017 |
Recall Event ID |
76712 |
510(K)Number |
K993425
|
Product Classification |
Accelerator, linear, medical - Product Code IYE
|
Product |
Mevatron M2/Primus Mid-Energy PRIMUS HI |
Code Information |
Device Model# 1940035, 4504200 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc 40 Liberty Blvd Malvern PA 19355-1418
|
For Additional Information Contact |
Marlynne Galloway 610-448-6478
|
Manufacturer Reason for Recall |
Software update
|
FDA Determined Cause 2 |
Software design |
Action |
Siemens mailed an Customer Information Letter on 02/15/2017 to affected customers to inform them of a software update they plan to implement to reduce risk of collision when delivering automatically sequenced treatments with automatic movements of the gantry and/or the treatment table, using the SIMTEC-Auto Field Sequence Option. |
Quantity in Commerce |
80 systems |
Distribution |
Distributed throughout the United States |
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 = IYE and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
|