Fischer Imaging Corporation 3/19/97 X-ray and mammography systems
(a) At least [purged word] systems observed with in-process component and system mis-assemblies such as miswired parts; incorrect or defective printed circuit boards (PCB); missing hardware; defective computer or monitor; incorrect labeling; and defective components such as hand switches, foot switches, collimators, radiation detectors, x-ray tube, cables, a bucky, a consoles, and a power supply. Some of these systems later were found to have defects during installation at the user facility, such as missing hardware, incorrect or defective PCB’s, incorrect software version, miswired parts, and radiation leakage. These systems included, but were not limited to: [purged text]
(i) The procedure indicated that validation references will only be required for software changes, but does not assure a documented analysis that provides the rationale for validation, or the decision to not validate.
(ii) The procedure does not assure that validation protocols were generated defining the extent and scope of the validation, including the degree of testing necessary to assure proper function of the system following the change.
(iii) The [purged text] procedure [purged text] pertains to validation of new or a major revision of an in-circuit test fixture or program, i.e., the [purged text] and includes validation specifically intended to be used when software changes are made. However, these forms are not always used. For example, they were not used for the following changes which were recorded in a [purged text] Log:
7. The [purged text] Procedure [purged text] included maintenance and calibration procedures which were not always followed, in that records did not always indicate the performance of required daily, weekly, monthly maintenance and operational checks, and corrective actions taken when software or system failures occurred.
