Events

Recall of Device Recall digital breast tomosynthesis

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73307
  • Event Risk Class
    Class 2
  • Event Number
    Z-0888-2016
  • Event Initiated Date
    2016-02-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143817
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Digital breast tomosynthesis - Product Code OTE
  • Reason
    A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. the data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (gpu). if the fatal error message occurs, reconstruction of the data will be aborted. the syste.
  • Action
    Siemens sent a Field Safety Notice dated February 11, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. How will the issue finally be resolved? Siemens is releasing a field modification to resolve this issue as soon as possible. The upgrade software (VB30P) will be available to the affected customers free of charge. A Siemens service engineer will contact you to schedule implementation of the modification for your system. According to regulations set forth in 21 CFR 7.49(d), we advise that you follow the instructions in this notice and where necessary request that you promptly notify and instruct all the staff at your organization who have to be aware of this problem. If the device has been sold and therefore no longer in your possession, please forward this notice to the new owner. We would also request that you inform us of the identity of the device's new owner where possible. Please observe this safety notice and comply with the corresponding measure until the update has been fully completed. We thank you for your cooperation. For further questions, please call (610) 448-6478.

Device

Device Recall digital breast tomosynthesis
  • Model / Serial
    Model number: 10140000
  • Product Classification
    Radiology Devices
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico and to the states of : AR, CA, CO, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, NC, NE, NH, NJ, NY, OH, PA, SC, TN, TX, VA and WI.
  • Product Description
    Mammomat Inspiration with Tomosynthesis functionality
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA