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FDA Medical Device Recalls (openFDA)

Northwest Medical Physics Equipment Inc: Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.

Recall number
Z-1145-2007
Recalling firm
Northwest Medical Physics Equipment Inc
Product
Isoloc software Versions 6.5 and 4.5, Part Number NT-NW-425-520. Software for image guided radiation therapy.
Status
Terminated
Initiated
2006-01-02
Posted
2007-08-08
Terminated
2011-04-19
Reason
Isoloc version 6.5 and 4.5 software issued a false warning message regarding Gantry angles when set to "Anatomic Landmark" setting.
Root cause
Software design
Action
Software to fix the described problem was written and customers contacted by e-mail on 01/06/2006 that a software patch, titled 01022006 was available to their customers on the firm's internet website.
Quantity
132
Distribution
Nationwide, Korea, Spain, and UK.
Lot, serial or model codes
Software version: Isoloc 6.5 and Isoloc 4.5
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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