Integra XKnife Stereotactic Radiosurgery and Radiotherapy Treatment Planning, Software Versions 5.0.1 and 5.0.2. Intende
FDA device recall Z-1103-2013 · posted 2013-04-12 · Terminated
Recall details
- Recalling firm
- Integra LifeSciences Corp.
- Reason for recall
- 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.
- Action taken
- Integra initiated a voluntary recall on December 10, 2012 by providing a written Urgent: Medical Device Recall Notification to US consignees who have experienced the software issue due to the configuration of their system. The letter identifies the affected product, as well as, advises customers of the nature of the issue and how it affects treatment records. - Advises customers that they will be contacted when V 5.0.3 software, where the software error has been addressed, is available to schedule an upgrade. - Requests that customer consignees complete and return the Product Recall Acknowledgment Form. If customer have additional questions, they should contact the firm's service hotline at 1-888-772-7378.
- Root cause
- Software design
- Status
- Terminated
- Product code
- MUJ
- Quantity affected
- 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.
- Date initiated
- 2012-12-10
- Date posted
- 2013-04-12
- Date terminated
- 2013-08-01
- Location
- Plainsboro, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| XKNIFE 5 (K100417) | Integra Radionics, Inc. | 2010-04-08 |