ISOLOC Software Version 6.0, Part Number NT-NW-425-520. Localization software for radiotherapy treatment system.
FDA device recall Z-1154-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- When ISOLOC version 6.0 software was used in the Anatomic Landmark mode, the couch moves display in the Couch Translator window was incorrect.
- Action taken
- Software to fix the described problem was written and customers contacted by e-mail on 12/30/2004 that a software patch, titled 12302004 was available to their customers on the firm's internet website.
- Root cause
- Software design
- Status
- Terminated
- Product code
- IYE
- Quantity affected
- 79
- Distribution
- Worldwide, including USA, Korea, Spain, and UK.
- Date initiated
- 2004-12-30
- 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 |