Z-2230-2008

Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Model Number(s)...

Name: Z-2230-2008 Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Model Number(s)...
Creator: Siemens Medical Solutions USA, Inc.
Published: 2008-06-06
License: https://open.fda.gov/license/

Siemens Medical Solutions USA, Inc. / initiated 2008-06-06 / Terminated / root cause: manufacturing process

FDA source

Siemens Medical Solutions USA, Inc. began a recall of Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Model Number(s): 10035724, used with System Models: 08245875, 08246951... on 2008-06-06. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2230-2008
Status: Terminated
Initiated: 2008-06-06
Posted: 2008-09-11
Terminated: 2010-12-21
Recalling firm: Siemens Medical Solutions USA, Inc.
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.
Product code: IYO System, Imaging, Pulsed Echo, Ultrasonic
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.
Root cause tag: manufacturing process
FDA root cause: 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.
Product codes and lots: Serial numbers beginning with 735 and lower.

Product code IYO

K063085Class IIModification to Acuson Sequoia Ultrasound SystemSiemens Medical Solutions USA, Inc. / cleared 2006-11-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)