Recall Z-2137-2008 ยท IYE Accelerator, Linear, Medical
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.
| Date | Sep 18, 2008 (initiated Jun 18, 2008) |
| Status | Terminated |
| Reason | A localization may be produced which has the incorrect moves, and therefore, could place the patient in the incorrect location. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K904908 | STEREOTACTIC IRRADIATION SYSTEM Northwest Medical Physics Center, Jun 6, 1991 |