Reported Apr 9, 2014 · Terminated
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear…
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?
- Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
- Lot codes and dates
496 of 496 codes
152718152003152007151963152081151693152131152318105792105570152778151052152363152472152195153022152689152640152642152663152680152782152796152829152862152962153030153125153244153270153211153296152834152596151354151353152664151200151823151822151610152026152027152692151276152856151106152877152986152810105935153105153069151023152914151975151240151239153135105810
- Amount recalled
- 498
Where it was sold
Why it was recalled
The problem is that the "static tolerances" from the calibration files (loaded database) are used for beam delivery instead of the machine calculated values.
This product could cause temporary or reversible health problems — stop using it.
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