Civco Medical Instruments Inc 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Civco Medical Instruments Inc
Lot Codes / Batch Numbers
Versions 6.6, 6.5 and 6.0
Products Sold
Versions 6.6, 6.5 and 6.0
Civco Medical Instruments Inc is recalling Isoloc Software, Version 6.6, 6.5 and 6.0. Part Number MT-NW-425-520. Software computer hard disc due to A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
PR
Page updated: Jan 10, 2026