ACUSON Sequoia C512/512SS Adv PE 10.0 System, model number 10041127. Distributed by Siemens Medical Solutions USA, Inc.,
FDA device recall Z-2115-2011 · posted 2011-04-29 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- Shock Hazard. The manufacturer failed to set the system power switch to "ON" during the line level leakage and high pot current draw testing.
- Action taken
- Siemens Medical Solutions USA, Inc. sent a Customer Safety Advisory Notification letter out on May 15, 2009. Service engineers were to visit each customer to conduct necessary testing. For questions regarding this recall call 650-694-5993.
- Root cause
- Release of Material/Component prior to receiving test results
- Status
- Terminated
- Product code
- IYN
- Quantity affected
- 4 units
- Distribution
- Worldwide Distribution - USA including CA, IL, MD, NC, OH, and UT and the countries of Australia, China, Denmark, Spain, South Korea, Norway, Poland, Russia and Sweden.
- Date initiated
- 2009-05-15
- Date posted
- 2011-04-29
- Date terminated
- 2011-04-29
- Location
- Mountain View, CA
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