Reported Dec 3, 2014 · Terminated
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic…
Vision Rt 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: Vision Rt Inc · 8840 Stanford Blvd · Columbia, MD · 21045-5827
Is this the product you have?
- AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
- Lot codes and dates
- Affected software versionSoftware versions 5.0.1738 and 5.0.1742 only
- Affected serial numbers
248-052248-066248-088249-0059249-0133249-0134249-0139
- Amount recalled
- 7 (Six Units distribited in the US and One in OUS.)
Where it was sold
Why it was recalled
Potential failure of AlignRT to assert interlock.
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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