Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.
FDA device recall Z-1145-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
- Action taken
- Software to fix the described problem was written and customers contacted by e-mail on 01/06/2006 that a software patch, titled 01022006 was available to their customers on the firm's internet website.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 132
- Distribution
- Nationwide, Korea, Spain, and UK.
- Date initiated
- 2006-01-02
- 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 |