Reported Mar 20, 2013 · Terminated

Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation…

Elekta, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Elekta, Inc. · 400 Perimeter Center Ter Ne · Atlanta, GA · 30346-1227

Is this the product you have?

  • Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Lot codes and dates
  • 164 of 164 codes

    • 151055
    • 151700
    • 151809
    • 151695
    • 151479
    • 151696
    • 151867
    • 151704
    • 151765
    • 151860
    • 151024
    • 151521
    • 151803
    • 152217
    • 151774
    • 152220
    • 151626
    • 151842
    • 151847
    • 151446
    • 151801
    • 151953
    • 151664
    • 151751
    • 151352
    • 151298
    • 151728
    • 151504
    • 151981
    • 151705
    • 151977
    • 152123
    • 152126
    • 151955
    • 105982
    • 151160
    • 151634
    • 151954
    • 151416
    • 151074
    • 151587
    • 151729
    • 151694
    • 151965
    • 151418
    • 151674
    • 151259
    • 151698
    • 151699
    • 152043
    • 151636
    • 151811
    • 151568
    • 151258
    • 151584
    • 151423
    • 151623
    • 151627
    • 151507
    • 151640
Amount recalled
164

Where it was sold

Why it was recalled

The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Elekta, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jul 14, 2021 · Data as of Sep 19, 5:38 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.