Events

Recall of Device Recall Siemens syngo.plaza with software version VA20B_HF04

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
    61141
  • Event Risk Class
    Class 2
  • Event Number
    Z-1127-2012
  • Event Initiated Date
    2012-01-20
  • Event Date Posted
    2012-02-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107379
  • 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
    System, image processing, radiological - Product Code LLZ
  • Reason
    There is a potential malfunction when using syngo.Plaza va20b_hf04 with usb dongle and archive license. in syngo.Plaza va20b_hf04, there is a scenario where data in short-term storage (sts) could reaming unprotected and not archived. this can happen when an archive server with a usb dongle-based license is enabled with auto archiving. if the disk fill level is reached which triggers auto deleti.
  • Action
    Siemens sent a Customer Safety Advisory Notice letter dated January 20, 2012 to all affected consignees. The letter identified the affected product, problem, steps to take to avoid this issue, and actions to be taken. Customers were instructed to contact their local Siemens Service to plan for their software update and ensure that this safety advisory is placed in the system's instruction for use.

Device

Device Recall Siemens syngo.plaza with software version VA20B_HF04
  • Model / Serial
    Model number 10592457 - serial numbers 100138, 100263, 100249, 100201, 100198, 100181 and 100146.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution (USA) - CA, FL, GA, MO, NY and WA.
  • Product Description
    Siemens syngo.plaza with software version VA20B_HF04 || Product Usage: || Radiological image processing system
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA