Z-1146-2007

ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment

Name: Z-1146-2007 ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment
Creator: Northwest Medical Physics Equipment Inc
Published: 2006-04-07
License: https://open.fda.gov/license/

Northwest Medical Physics Equipment, Inc. / initiated 2006-04-07 / Terminated / root cause: software

FDA source

Northwest Medical Physics Equipment Inc began a recall of ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment on 2006-04-07. The reason FDA records is "This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1146-2007
Status: Terminated
Initiated: 2006-04-07
Posted: 2007-08-08
Terminated: 2011-04-19
Recalling firm: Northwest Medical Physics Equipment, Inc.
Product: ISOLOC 6.5 Software Part Number NT-NW-425-520. Software for radiotherapy treatment.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: This correction was for several software bugs which caused image format problems; incorrect ruler display; software crashes; failure to update pixel spacing; display of unattainable treatment table positions; failure to update gantry angles; wrong shifts for two of three axes of treatment table movement.
Root cause tag: software
FDA root cause: Software design
Action: Software to fix the problems was written and software users were notified of the availability by e-mail on 04/07/2006. They could download the fixed software from the firm's internet website.
Quantity in commerce: 141 copies
Distribution: Customers in USA, Korea, Spain and UK.
Product codes and lots: ISOLOC 6.5 version, Part Number NT-NW-425-520

Product code IYE

K904908Class IIStereotactic Irradiation SystemNorthwest Medical Physics Center / cleared 1991-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)