Z-1153-2007

ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position...

Name: Z-1153-2007 ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position...
Creator: Northwest Medical Physics Equipment Inc
Published: 2005-04-11
License: https://open.fda.gov/license/

Northwest Medical Physics Equipment, Inc. / initiated 2005-04-11 / Terminated / root cause: software

FDA source

Northwest Medical Physics Equipment Inc began a recall of ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy on 2005-04-11. The reason FDA records is "When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 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-1153-2007
Status: Terminated
Initiated: 2005-04-11
Posted: 2007-08-08
Terminated: 2011-04-19
Recalling firm: Northwest Medical Physics Equipment, Inc.
Product: ISOLOC Software Version 6.0, Localization software for determining treatment machine position (to position patients) for high accuracy radiotherapy.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: When ISOLOC version 6.0 was used in the centimeter mode, the display in the couch moves window had a rounding error relative to the Portal Image Marker window of up to 0.5 mm.
Root cause tag: software
FDA root cause: Software design
Action: Software to fix the described problem was written and customers contacted by e-mail on 04/11/2005, that a software patch, titled 04112005, was available to their customers on the firm's internet website.
Quantity in commerce: 84
Distribution: Worldwide, including USA, Korea, Spain, and UK.
Product codes and lots: ISOLOC Software Version 6.0, 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)