ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for
FDA device recall Z-1153-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
- Action taken
- Software to fix the described problem was written and customers contacted by e-mail on 04/11/2005, that a software patch, titled 04112005, was available to their customers on the firm's internet website.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 84
- Distribution
- Worldwide, including USA, Korea, Spain, and UK.
- Date initiated
- 2005-04-11
- 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 |