ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.
FDA device recall Z-1152-2007 · posted 2007-08-08 · Terminated
Recall details
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Reason for recall
- When ISOLOC version 6.0 and 4.2 distance unit is set to centimeter, the localization coordinates were rounded to the nearest millimeter which could affect positioning by 0.5 mm.
- Action taken
- Software to fix the described problems was written and customers contacted by e-mail on 04/28/2005, that a software patch, titled 04282005, was available 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
- 2005-04-28
- Date posted
- 2007-08-08
- Date terminated
- 2011-04-20
- 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 |