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.
FDA Recall Z-2137-2008 · Posted 2008-09-18
Recalling FirmCivco Medical Instruments Inc
Recall StatusTerminated
Product CodeIYE
Date Initiated2008-06-18
Date Terminated2011-03-31
Product Quantity235: 163 version 6.6, 60 version 6.5 and 12 version 6.0
Reason for Recall
A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.