Date Initiated by Firm |
August 05, 2008 |
Date Posted |
September 29, 2008 |
Recall Status1 |
Terminated 3 on December 21, 2010 |
Recall Number |
Z-2468-2008 |
Recall Event ID |
49377 |
510(K)Number |
K052894
|
Product Classification |
Ultrasound System - Product Code IYN
|
Product |
Sonoline G50/G60 Ultrasound System, Software versions 1.0.0 to 1.5.0b. The product is a general purpose, mobile software controlled diagnostic ultrasound system. |
Code Information |
Model numbers 07482800, 07482818, 07482826, 07478139, 07478147, and 07482479 |
Recalling Firm/ Manufacturer |
Siemens Medical Solutions USA, Inc. 1230 Shorebire Way P.O. Box 7393 Mountain View CA 94043
|
For Additional Information Contact |
650-694-5993
|
Manufacturer Reason for Recall |
As a result of bugs and calculation errors, the system may display incorrect or fail to display mechanical Index and thermal index values.
|
FDA Determined Cause 2 |
Software design |
Action |
The firm initiated its field correction on 08/05/2008. The firm's service personnel will make site visits to correct the problem and install the revised software (version 1.5.0c). Contact Siemens Medical Solutions USA, Inc. at 1-650-694-5993 for assistance. |
Quantity in Commerce |
2541 units |
Distribution |
Worldwide |
Total Product Life Cycle |
TPLC Device Report
|
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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 = IYN and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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