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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens Ultrasound Transducer 17L5HD

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  Class 2 Device Recall Siemens Ultrasound Transducer 17L5HD see related information
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  
Product Classification Transducer - Product Code IYO
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
For Additional Information Contact Ms. Sheila Pickering
650-694-5993
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.
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
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 = IYO and Original Applicant = SIEMENS MEDICAL SOLUTIONS USA, INC.
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