ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.
FDA device recall Z-1147-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- When the ISOLOC (Version 4.2) profile distance unit is set to "centimeter" and the user clicked the "back" button in the digitizer window, the marker and target coordinates in the localization window erroneously display values ten times greater than the correct values.
- Action taken
- Software to fix the described problems was written and customers contacted by e-mail on 05/31/2005, that a software patch, titled 05312005 was available on the firm's internet website.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 85
- Distribution
- Worldwide, including USA, Korea, Spain, and UK.
- Date initiated
- 2005-05-31
- 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 |