Fischer Imaging X-ray and mammography systems

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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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