BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-1331-2014 · Initiated March 7, 2014

    Recall

    Recall Number
    Z-1331-2014
    Event Number
    67741
    Firm
    Siemens Medical Solutions USA, Inc.
    FEI Number
    2936884
    Product Code
    IYN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 7, 2014
    Posted
    April 3, 2014
    Terminated
    November 12, 2015
    Address
    685 E Middlefield Rd, Mountain View, CA, 94043-4045

    Description

    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.

    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.

    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 share this information with all personnel within your organization who need to be aware of this issue. As always, patient safety issues are a high priority. To date, no patient injury has been reported. This problem was discovered as part of our ongoing quality process. For further questions please call (650) 694-5398. We sincerely regret any inconvenience this condition may cause in your daily operations.

    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, Kuwait, Malaysia, Mauritius, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Republic Korea, Romania, Saudi Arabia, Serbia, Seychelles, Singapore, South Africa, Spain, Switzerland, Taiwan, Trinidad,Tobago, Turkey, U.A.E. and United Kingdom.

    Quantity

    675