Prucka 30-June-99 Multi-channel electrocardiographic amplifiers, CardioLab EP System and CardioCath Catheterization Lab System software 2. Failure to establish and maintain procedures for validation of the device design, including software validation, and documentation of the validation, as required by 21 CFR 820.30(g). For example: a. Standard operating procedures have not been established for software validation. b....Read More

30-June-99 C30-June-99 Kavo Dental 7 units. Class III. AC powered dental drilling device. Software error may cause unit to shutdown prior to reaching preset torque limit. Z-1215-9Read More