Reported Feb 18, 2015 · Terminated
Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as…
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?
- Precise Digital Accelerator Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner.
- Lot codes and dates
153602153538153561153569153532153556153566153563153564153589153530153531153562153584153615153534153534153535153563153542153542153548153548153558153578153595153699153630153728153680153712. 153717153723153734153702153715153684153710153577153725153726153691153696153713153724153727
- Amount recalled
- 46
Where it was sold
Why it was recalled
Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
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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