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
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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
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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.
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510(K) Database | 510(K)s with Product Code = IYN
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