Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia Ultrasound System; Model Number(s): 10035724, used w
FDA device recall Z-2230-2008 · posted 2008-09-11 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- IYO
- Quantity affected
- 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,
- Date initiated
- 2008-06-06
- Date posted
- 2008-09-11
- Date terminated
- 2010-12-21
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM (K063085) | Siemens Medical Solutions USA, Inc. | 2006-11-14 |