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FDA Medical Device Recalls (openFDA)

Northwest Medical Physics Equipment Inc: ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.

Recall number
Z-1155-2007
Recalling firm
Northwest Medical Physics Equipment Inc
Product
ISOLOC Software Version 4.2, Part Number NT-NW-425-520. Image guided radiation treatment software.
Status
Terminated
Initiated
2004-11-30
Posted
2007-08-09
Terminated
2011-04-19
Reason
When ISOLOC Version 4.2 unit is set to centimeter and the user clicks the Reenter button in the digitizer window, the coordinates of the markers and target in the anatomic imaging system erroneously displays values ten times greater than the correct values.
Root cause
Software design
Action
Software to fix the described problem was written and customers contacted by e-mail on 11/30/2004, that a software patch, titled 11302004, was available to their customers on the firm's internet website.
Quantity
83
Distribution
Worldwide, including USA, Korea, Spain, and UK.
Lot, serial or model codes
ISOLOC Software 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

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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

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