Reported Nov 3, 2021 · Ongoing
Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00
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 users using version 4.0 and above with Applicator Modeling license 170283-00
- Lot codes and dates
- Oncentra Brachy users using version 4.0 and above with Applicator
- Modeling license 170283-00 GTIN Numbers
0871721305275808717213038660087172130206100871721305232108717213052314087172130523070871721305229108717213052246087172130522390871721305188108717213051843087172130517820871721305177508717213051294087172130206100871721305371708717213053700
- Amount recalled
- 1072 devices
Where it was sold
Why it was recalled
Under certain circumstances, there can be a difference between the planned and delivered dose of the two ovoid channels.
This product could cause temporary or reversible health problems — stop using it.
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