Integra XKnife¿ Stereotactic Radiosurgery and recall: Software Issue
Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and…
Why was Integra XKnife¿ Stereotactic Radiosurgery and recalled?
Depending on the system configuration, a software error message in versions 5.0.1 and 5.0.2. occurs if a beam plan is transmitted from XKnife using DICOM-RT.
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?
Software Versions 5.0.1 and 5.0.2.
- Product
- Integra XKnife¿ Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intended for use in stereotactic and…
- Recalling firm
- Integra LifeSciences Corp.
- Quantity
- 11 XKnife V5.0.1 and 1 XKnife V5.0.2
- Distribution
- Distributed in the states of IL, ID, LA, MA, NJ, NY, OH, PA, and SD.
- Recall date
- April 24, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)