FDA Medical Device Recalls (openFDA)
Northwest Medical Physics Equipment Inc: ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.
- Recall number
- Z-1147-2007
- Recalling firm
- Northwest Medical Physics Equipment Inc
- Product
- ISOLOC 4.2 Software Part Number NT-NW-425-520. Image guided radiation treatment software.
- Status
- Terminated
- Initiated
- 2005-05-31
- Posted
- 2007-08-08
- Terminated
- 2011-04-19
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 85
- Distribution
- Worldwide, including USA, Korea, Spain, and UK.
- Lot, serial or model codes
- ISOLOC Version 4.2 Part Number NT-NW-425-520.
- 510(k) numbers
- ["K904908"]
- PMA numbers
- not on file
- Product code
- IYE
- Firm FEI
- 1000126033
- Firm city
- Everett
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28