ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.
FDA device recall Z-1155-2007 · posted 2007-08-09 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
- Action taken
- Software to fix the described problem was written and customers contacted by e-mail on 11/30/2004, that a software patch, titled 11302004, was available to their customers on the firm's internet website.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 83
- Distribution
- Worldwide, including USA, Korea, Spain, and UK.
- Date initiated
- 2004-11-30
- Date posted
- 2007-08-09
- 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 |