—#71909

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.

FDA product code: IYO — System, Imaging, Pulsed Echo, Ultrasonic
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K063085
Affected lot / code info: Serial numbers beginning with 735 and lower.

Why it was recalled

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.

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Siemens Medical Solutions USA, Inc.
Address: 1230 Shorebire Way P.O. Box 7393, Mountain View, California 94043

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2008-06-06
Posted by FDA: 2008-09-11
Terminated: 2010-12-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71909. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.