Recall Z-1331-2014 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Siemens Medical Solutions USA, Inc.
Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.
| Date | Apr 3, 2014 (initiated Mar 7, 2014) |
| Status | Terminated |
| Reason | ACUSON P300 ultrasound systems using the PA230 transducer with a user-defined preset which includes the 100% setting for output power could cause the transducer surface temperature to exceed the maximum allowable limit. |
| Root cause | Device Design |
| Action | Siemens sent an Customer Safety Advisory Notifications on March 7, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new version of software resolving this error will be provided free of charge. Your local Customer Service Engineer will contact you to schedule an appointment to make the necessary repairs on your system. If you have any questions, please contact your local service support person for information regarding timelines and status. Until the necessary repairs have been completed on your system, please |
| Quantity | 675 |
| Distribution | Class II Recall - Worldwide Distribution - US Distribution and the countries of Australia, Austria, Belgium, Bhutan, Bolivia, Botswana, Bulgaria, Canada, Chile, Colombia, Croatia, Dem. Rep. Congo, Denmark, Ecuador, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Ivory Coast, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121384 | MYLABSOGNO Esaote, S.p.A., May 23, 2012 |