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
151055151700151809151695151479151696151867151704151765151860151024151521151803152217151774152220151626151842151847151446151801151953151664151751151352151298151728151504151981151705151977152123152126151955105982151160151634151954151416151074151587151729151694151965151418151674151259151698151699152043151636151811151568151258151584151423151623151627151507151640
- 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.
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