Events

Recall of Device Recall SEQUENCER for Mosaiq

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Impac Medical Systems 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
    55087
  • Event Risk Class
    Class 2
  • Event Number
    Z-1029-2011
  • Event Initiated Date
    2010-03-10
  • Event Date Posted
    2011-02-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90908
  • 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
    Medical Linear Accelerator - Product Code IYE
  • Reason
    Computer interface is defected. computer based verification system for recording patient treatment on a radiotherapy treatment machine fails to record treated field.
  • Action
    A User Notice was sent by the firm to its consignees. It identified the affected product and the reason for the recall. It also discussed the clinical impact and interim mitigations. The firm states in the letter that a fix for the problem and been developed and is available. Customers are to contact IMPAC Support for the patch to the SL75-5 interface. If customers have questions, concerns, or requests, they can email support@impac.com or one of the numbers listed in the letter for the applicable country. The letter should be distributed to all users affected by the issue at the customer's organization.

Device

Device Recall SEQUENCER for Mosaiq
  • Model / Serial
    Sequencer for MOSAIQ versions: 1.20, 1.30 ; 1.50 , 1.60 and 2.00, interfacing to an Elekta SL 75-5 Linacs.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- US, Canada, Germany, and France.
  • Product Description
    SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. || Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.
  • Manufacturer
    Impac Medical Systems Inc

Manufacturer

Impac Medical Systems Inc
  • Manufacturer Address
    Impac Medical Systems Inc, 100 Mathilda Pl Fl 5th, Sunnyvale CA 94086-6076
  • Manufacturer Parent Company (2017)
    Impac Medical Systems Inc
  • Source
    USFDA