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U.S. Department of Health and Human Services

Class 2 Device Recall ISOLOC Software

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 Class 2 Device Recall ISOLOC Softwaresee related information
Date Initiated by FirmJune 18, 2008
Date PostedSeptember 18, 2008
Recall Status1 Terminated 3 on March 31, 2011
Recall NumberZ-2137-2008
Recall Event ID 48463
510(K)NumberK904908 
Product Classification Linear Medical Accelerator - Product Code IYE
ProductIsoloc 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.
Code Information Versions 6.6, 6.5 and 6.0
Recalling Firm/
Manufacturer		 Civco Medical Instruments Inc
102 1st St S
Kalona IA 52247-9589
For Additional Information Contact
425-672-2841
Manufacturer Reason
for Recall		A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
FDA Determined
Cause 2		Software design
ActionOn 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 Commerce235: 163 version 6.6, 60 version 6.5 and 12 version 6.0
DistributionWorldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = IYE
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