Z-1152-2007

ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software

Name: Z-1152-2007 ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software
Creator: Northwest Medical Physics Equipment Inc
Published: 2005-04-28
License: https://open.fda.gov/license/

Northwest Medical Physics Equipment, Inc. / initiated 2005-04-28 / Terminated / root cause: software

FDA source

Northwest Medical Physics Equipment Inc began a recall of ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software on 2005-04-28. The reason FDA records is "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". 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-1152-2007
Status: Terminated
Initiated: 2005-04-28
Posted: 2007-08-08
Terminated: 2011-04-20
Recalling firm: Northwest Medical Physics Equipment, Inc.
Product: ISOLOC Software Versions 6.0 and 4.2. Part Number NT-NW-425-520. Image guided radiotherapy treatment software.
Product code: IYE Accelerator, Linear, Medical
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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 84
Distribution: Worldwide, including USA, Korea, Spain, and UK.
Product codes and lots: ISOLOC Software Versions 6.0 & 4.2 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)