FDAFDA · Food and drugs·Recall number Z-0464-2015
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.
Published December 3, 2014 · Recall initiated: October 15, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Potential failure of AlignRT to assert interlock.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Vision Rt Inc
- Distributor
- Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
- Lot
- Affected software version: Software versions 5.0.1738 and 5.0.1742 only. Affected serial numbers: 248-052, 248-066, 248-088, 249-0059, 249-0133, 249-0134, 249-0139.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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