ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
FDA device recall Z-1146-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
- Action taken
- Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 141 copies
- Distribution
- Customers in USA, Korea, Spain and UK.
- Date initiated
- 2006-04-07
- Date posted
- 2007-08-08
- Date terminated
- 2011-04-19
- Location
- Everett, WA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STEREOTACTIC IRRADIATION SYSTEM (K904908) | Northwest Medical Physics Center | 1991-06-06 |