At the time of the inspection, a mammographic unit is found to not meet one or more of the specific equipment requirements listed in 21 CFR 900.12(b) (3-10). Must the unit immediately be taken out of service?
No. However, the unit must be replaced, modified or repaired as soon as possible. The facility may continue to use the unit for a limited time, as long as it takes measures to ensure that the failure to comply with the requirement does not result in substandard patient care. The facility is reminded that regardless of what is stated above, the unit must remain in compliance with the requirements listed in 21 CFR 900.12(e) if it is to be used on patients and the facility remains subject to citation for having a mammographic unit that did not meet one or more of the 21 CFR 900.12(b) requirements at the time of the inspection.