Reported Dec 21, 2022 · Ongoing
Oncentra Brachy radiation therapy planning system software.
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 Ste 50 · Atlanta, GA · 30346-1227
Is this the product you have?
- Oncentra Brachy radiation therapy planning system software.
- Lot codes and dates
- Version 4.0 and above with Applicator Modeling or Implant Modeling
- UDI GTIN numbers
0871721305275808717213038660087172130206100871721305232108717213052314087172130523070871721305229108717213052246087172130522390871721305188108717213051843087172130517820871721305177508717213051294087172130206100871721305371708717213053700
- Amount recalled
- 336 systems
Where it was sold
- Nationwide
- PR
Why it was recalled
A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
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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