Events

Recall of Device Recall IMPAC / Elekta Medicals Sequencer

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
    59347
  • Event Risk Class
    Class 2
  • Event Number
    Z-2983-2011
  • Event Initiated Date
    2011-06-30
  • Event Date Posted
    2011-08-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102338
  • 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 Image Storage System, Radiological - Product Code LMB
  • Reason
    A potential safety issue exists for data transfer between lantis ois system (containing primeview or primeview data gateway) and the sequencer v&r; system via a third party interface is used.
  • Action
    Siemens sent an "Update Instructions/Customer Safety Advisory Notice" to all affected users, beginning June 30, 2011. The letter includes description of the product and problem and provides updated instructions to ensure data is stored in the system. If you have questions contact Siemens at (925) 602-8157.

Device

Device Recall IMPAC / Elekta Medicals Sequencer
  • Model / Serial
    LANTIS Commander. Part Number 4503178; LANTIS system, Part Number 5835991; LANTIS 6.1 Commander, Part Number 5493072; LANTIS 8.3 Commander, Part Number 8148178  Linac Interface, other vendors: Part Number 4504994; LANTIS Varian Clinac, Part Number 1929251; LANTIS GE Saturn, Part Number: 1929277; LANTIS Philips SLS, Part Number 4507203; LANTIS Philips 75 ASU, Part Number 5494120; LANTIC Elekta (Philips), Part Number 5502880; LANTIS Varian EX I/F, Part Number 5846220.
  • Product Classification
    Radiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: Nationwide (USA) including the states of MI, DE, WI, FL, CA, TN, NJ, PA, NE, IL, WV , MA and VA; and the countries of Poland, France, Germany, Canada, Netherlands, India, Ireland, Egypt, P.R. china, Australia, Saudi Arabia, Turkey, Republic Korea, Belgium, Hungary, New Zealand, Italy, Malaysia, and Spain.
  • Product Description
    LANTIS Oncology Information System (OIS) || Manufactured by IMPAC/Elekta medical as Multi -Access OIS for Siemens. || An oncology digital imaging information management system. Lantis OIS in combination with Sequencer and a non-Siemens linac interface. || System components include: LANTIS Commander, LANTIS system, LANTIS 6.1 Commander, LANTIS 8.3 Commander. || Subcomponents include: Linac Interface, other vendor, LANTIS Varian Clinac, LANTIS GE Saturn, LANTIS Philips SLS, || LANTIS Philips 75 ASU, LANTIS Elekta (Philips) and LANTIS Varian EX I/F.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord CA 94520-1200
  • Source
    USFDA