AlignRT- Intended for prescription use. The system is recall
AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision…
Why was AlignRT- Intended for prescription use. The system is recalled?
Potential failure of AlignRT to assert interlock.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- AlignRT- Intended for prescription use. The system is indicated for use during simulation, setup and stereotactic radiosurgery and precision…
- Recalling firm
- Vision Rt Inc
- Quantity
- 7 (Six Units distribited in the US and One in OUS.)
- Distribution
- Worldwide Distribution: US distribution in states of: CA, MN, TX, and UT; and internationally to: Republic of Ireland.
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)