Events

Recall of Device Recall SOMATOM Scope

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
    75860
  • Event Risk Class
    Class 2
  • Event Number
    Z-0919-2017
  • Event Initiated Date
    2016-11-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151463
  • 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
    Siemens is providing a new installation of the residual current monitor (rcm) in the line connection box (lcb) to resolve a potential defect that could lead to a power cutout during use of the somatom scope, scope power and perspective systems.
  • Action
    Siemens mailed on December 01, 2016 a Customer Safety Notice to affected customers to inform them of a corrective action that is being performed to prevent a possible hazard to persons and equipment. The notice explained the underlying issue, the effect the issue has on the system, the associated risks and actions they will take to correct the issue. In addition, customers will receive a Customer Safety Notice via Hand Delivery from the Siemens Customer Service Engineer at the scheduled appointment for the corrective installation.

Device

Device Recall SOMATOM Scope
  • Model / Serial
    Model # 10967666 Serial Number:59376 91766 91767 115456 115454 59380 77560 98840 77557 91758 59377 59378 115451
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to: IL IL GA SC SD OK NY MI IN MD AR
  • Product Description
    SOMATOM Scope, Computed tomography x-ray system
  • 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