Company: MagneVu
Product: Portable magnetic resonance imaging (MRI) system
Date: 07/11/03

Software validation activities for computers or automated data processing systems used as part of production have not been performed or documented [21 CFR 820.70(i)]. Specifically, the Eng MagMRI software used for engineering and servicing of the MagneVu 1000 MRI System has not been validated.

Acceptance test results for the MagneVu 1000 MRI System were not adequately documented [21 CFR 820.80(c) and (d)]. Specifically, final acceptance records for release of the MagneVu 1000 MRI System did not document the results of the acceptance activities or equipment/software used in conducting the tests, and were not signed by the individual who performed the acceptance activities.

District: Los Angeles District Office