V5M TEE Transducer, when used with an ACUSON S2000 ultrasound system that has cardiac options installed and is at softwa
FDA device recall Z-1392-2011 · posted 2011-02-22 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc.
- Reason for recall
- If the transducer is not disconnected from the system after an automatic shutdown due to thermal limits being exceeded, then the next time it is used, the thermal safety guards do not take effect. Normally, the thermal limit before automatic image freeze (and therefore power shut off) occurs at 43 degrees Centigrade.
- Action taken
- Siemens sent a Customer Safety Advisory Notification letter on August 28, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that their local Customer Service Engineer would install a software update as soon as it becomes available. Customers were instructed to pass the Customer Safety Advisory Notification letter to all who need to be aware of these issues until the corrective action is completed. For questions regarding this recall call 650-969-9112 or 800-422-8766.
- Root cause
- Software design
- Status
- Terminated
- Product code
- ITX
- Quantity affected
- 97 units
- Distribution
- Worldwide Distribution - USA (nationwide) and internationally to Canada, China, Czech Republic, Denmark, Germany, Great Britian, Hong Kong, Indonesia, Italy, Japan, Norway, Poland, Portugal, Russian F
- Date initiated
- 2009-08-28
- Date posted
- 2011-02-22
- Date terminated
- 2011-03-29
- Location
- Mountain View, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM (K082142) | Siemens Medical Solutions USA, Inc., Ultrasound DI | 2008-11-13 |