Events

Recall of Symbia T16 System

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
    49456
  • Event Risk Class
    Class 2
  • Event Number
    Z-0190-2009
  • Event Date Posted
    2008-10-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73496
  • 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
    CT scanner - Product Code KPS
  • Reason
    The protective plastic cap over the ct gantry power switch on the line connection box may come loose, exposing the energized electrical contacts within the switch, thereby causing an electric hazard.
  • Action
    Siemens sent Customer Safety Advisory Notice/Urgent Field Correction Recall letters dated 9/29/08 to all users of the Symbia T6 and Symbia T16 Systems. The accounts were informed of the potential risk that the protective plastic cap over the CT gantry power switch could come loose, causing an electrical hazard. The customers were advised to avoid contact with the gantry power switch until the protective plastic cap has been replaced, and to leave the power switch on at the line connection box and cycle the CT gantry on and off by toggling the CT gantry circuit breaker within the circuit box. They also were advised that a Siemens Customer Service Representative would contact them within 90 days to schedule a corrective update to their Symbia system free of charge. The accounts were requested to complete and return the enclosed mandatory fax-back form to 1-865-218-3019, acknowledging the receipt and understanding of the 9/29/08 letter and providing their Symbia System model number and serial number. Contact Siemens Medical Solutions USA, Inc. at 1-800-767-2313 for assistance.

Device

Symbia T16 System
  • Model / Serial
    System part number 10275010, serial numbers 1001, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1009, and 1010; CT Subassembly 10165633, serial numbers 69003 through 69012
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide to the District of Columbia, Florida, Georgia, Illinois, Indiana, Missouri, Ohio, and Texas, and internationally to Australia, Brazil, Canada, Great Britain, India, Italy, Japan, Norway and Switzerland.
  • Product Description
    Symbia T16 System; a dual-detector variable angle gamma camera with a sixteen slice CT scanner; Siemens Medical Solutions USA, Inc., Molecular imaging, Hoffman Estates, IL 60192. The system is used to perform CT scans and nuclear imaging studies with the same instrument, obtaining attenuation corrected images and providing registration of anatomical and physiological images within the patient's anatomy. The Symbia T6 System is used for advanced oncology, neurology and cardiology applications.
  • Manufacturer
    Siemens Medical Solutions USA, Inc.

Manufacturer

Siemens Medical Solutions USA, Inc.
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc., 2501 Barrington Rd, Hoffman Estates IL 60195-2061
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA