Recall Z-2230-2008 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Siemens Medical Solutions USA, Inc.
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 intende
| Date | Sep 11, 2008 (initiated Jun 6, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063085 | MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM Siemens Medical Solutions USA, Inc., Nov 14, 2006 |