Events

Recall of SOMATOM Emotion 16

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
    71101
  • Event Risk Class
    Class 2
  • Event Number
    Z-1645-2015
  • Event Initiated Date
    2015-04-20
  • Event Date Posted
    2015-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137248
  • 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, x-ray, tomography, computed - Product Code JAK
  • Reason
    Software bugs in vc20b sp0a or sp1 software versions may cause issues that could make it necessary to rescan patients. syngo main ui may crash if the patient browser is scrolled with arrow keys of the keyboard. tomo images may freeze on the screen when zoomed in or out under the mode of carevision. sporadic displaying error in workstream4d application. db may lock under heavy and multitasks.
  • Action
    Siemens sent an Customer Safety Advisory Notice dated April 20, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A remote software update is scheduled for release that will resolve the issue. For further questions, please call (610) 219-6300.

Device

SOMATOM Emotion 16
  • Model / Serial
    SOMATOM Emotion 16 (2007) 10165977  with serial numbers:  86514 32490 80553 32552 32530 86406 86558 80542 80461 86405 32512 80441 86431 80467 86425 80442 86429 86557 80434 32581 32637 32597 80448 80431 32624 32469 80446 32578 80430
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including Puerto Rico.
  • Product Description
    SOMATOM Emotion 16, the intended use of computed tomography is to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angels or spiral planes taken at different angles.
  • 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 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA