Reported Jul 18, 2012 · Terminated
Focal SIM Planning of radiation therapy
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. · 4775 Peachtree Industrial Blvd · Norcross, GA · 30092-3011
Is this the product you have?
- Focal SIM Planning of radiation therapy
- Lot codes and dates
- Version 4.64.00 - 4.700, inclusive
- Amount recalled
- 38 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Incorrect patient shift directions when the Setup reference dialog is printed out when the DICOM coordinates option is enabled for reports.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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