Z-2137-2008

Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads...

Name: Z-2137-2008 Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads...
Creator: Civco Medical Instruments Inc
Published: 2008-06-18
License: https://open.fda.gov/license/

CIVCO Medical Instruments Co., Inc. / initiated 2008-06-18 / Terminated / root cause: software

FDA source

Civco Medical Instruments Inc began a recall of Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE... on 2008-06-18. The reason FDA records is "A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location". 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-2137-2008
Status: Terminated
Initiated: 2008-06-18
Posted: 2008-09-18
Terminated: 2011-03-31
Recalling firm: CIVCO Medical Instruments Co., Inc.
Product: Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc reads "ISOLOC 6.6 Copyright NMPE Copyright 1997-2004 NMPE Build #10302006 CIVCO MEDICAL SOLUTIONS Is an EPID-based (electronic portal imaging device) version of localization software for determining the treatment machine position of radiotherapy targets.
Product code: IYE Accelerator, Linear, Medical
Reason for recall: A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
Root cause tag: software
FDA root cause: Software design
Action: On 06/16/08 Civco Medical Solutions issued an Urgent-Medical Device Correction letter to all its customers by certified mail. This letter states the circumstances in which the device works incorrectly, a temporary work around and the information that the new software version 6.7 will address the issue. The software will be released in August of 2008. Attached to the letter is an ISOLOC Device Correction Notification Customer Feedback form which is to be completed and returned acknowledging the receipt of the Device Correction Notification.
Quantity in commerce: 235: 163 version 6.6, 60 version 6.5 and 12 version 6.0
Distribution: Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
Product codes and lots: Versions 6.6, 6.5 and 6.0

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)