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Class 2 Device Recall Siemens Ultrasound Transducer 17L5HD |
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Date Initiated by Firm |
June 06, 2008 |
Date Posted |
September 11, 2008 |
Recall Status1 |
Terminated 3 on December 21, 2010 |
Recall Number |
Z-2230-2008 |
Recall Event ID |
48695 |
510(K)Number |
K063085
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Product Classification |
Transducer - Product Code IYO
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Product |
Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Model Number(s): 10035724, used with System Models: 08245875, 08246951, 08255412, 08255413, 08267697, 08269627, 10038241, 10038242, 10040724, 10040725, 10041008;
Product is manufactured and distributed by Siemens Medical Solutions USA, Inc. Ultrasound Division, Mountain View, CA
The 17L5 transducer is intended for breast and small body parts imaging. |
Code Information |
Serial numbers beginning with 735 and lower. |
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 |
Ms. Sheila Pickering 650-694-5993
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Manufacturer Reason for Recall |
The product assembly can cause a failure of the transducer which results in a double and/or overlapped image which may ultimately result in misleading or false information, inability to accurately diagnose, incorrect positioning/locating/insertion of the biopsy needle and/or an interruption during the biopsy procedure.
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FDA Determined Cause 2 |
Process control |
Action |
On 6/6/08, the firm initiated the recall and its notification was via letters explaining the reason for the recall and requesting the affected product be returned. Affected transducers will be replaced. For assistance, contact Siemens Medical Solutions at 1-650-694-5993. |
Quantity in Commerce |
388 units |
Distribution |
Worldwide Distribution: USA, AUSTRALIA, AUSTRIA, CANADA, CHINA, DENMARK, FRANCE, GERMANY, INDIA,
ITALY, JAPAN, KOREA, MALAYSIA, MEXICO, NORWAY, PORTUGAL,
RUSSIAN FEDERATION, SINGAPORE, SWEDEN, TAIWAN, and
THAILAND. |
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 = IYO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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