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
- Recall Number
- Z-2137-2008
- Event Number
- 48463
- Firm
- Civco Medical Instruments Inc
- FEI Number
- 1937223
- Product Code
- IYE
- Status
- Terminated
- Root Cause
- Software design
- Initiated
- June 18, 2008
- Posted
- September 18, 2008
- Terminated
- March 31, 2011
- Address
- 102 1st St S, Kalona, IA, 52247-9589
Description
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.
A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location.
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.
Worldwide Distribution --- USA including Puerto Rico and countries of Korea, Portugal, and United Kingdom.
235: 163 version 6.6, 60 version 6.5 and 12 version 6.0