A review of radiology cases at University Hospital Kerry has found that 11 patients had their cancer diagnoses delayed, and four of these patients have since died.
A look-back report has been published by the South/South West Hospital Group.
The review was of all radiology images reported by a single consultant radiologist at the hospital between March 2016 to July 2017.
It was prompted by the notification of three "serious reportable events", each resulting in a diagnostic error, in July and August 2017.
It said 11 patients had their diagnosis delayed, which had a "serious impact on their health".
This included the three initial cases which prompted the review.
It also found that three patients had undiagnosed cancer, which had not previously been identified.
'Unreported findings'
As part of the audit, a review of 46,234 images - including CT scans, ultrasounds and chest x-rays - was carried out, relating to 26,754 individual patients between March 2016 and July 2017.
Some 1,789 radiology reports were reviewed against other clinical records to determine if the patient had appropriate follow-up care at the time of the original examination.
Some 422 patients were identified for recall.
Following repeat imaging, 59 patients required further clinical follow-up and/or investigations - and 10 patients were referred to other hospitals for specialist care.
The look-back review found that there was a "substantial rate" of unreported clinically significant findings, requiring clinical review to determine if patients should be recalled for imaging.
The review was designed to identify patients who may need on-going and additional care and was not an individual professional review.
A key finding of the audit also noted that while patients were exposed to risk, the majority of patients "did not suffer any direct harm due to the diligence of their treating doctors."
It has also made a number of recommendations - including an external review of the management of the radiology department at the hospital, a review and enhancement of the incident reporting process in the hospital and a definition of acceptable volumes of work for individual radiologists.
"Apologise sincerely and unreservedly"
In a statement, the hospital group said: "First and foremost, the South/South West Hospital Group, University Hospital Kerry and the Health Service Executive (HSE) would like to apologise sincerely and unreservedly to all patients and families who have been affected by this review."
The look-back review was carried out in accordance with the HSE Guidance for the Implementation of a Look-back Review Process.
The hospital group said all these cases are the subject of further on-going system analysis review investigations, which are being shared with individual patients and their families.
Dr Gerard O'Callaghan is chair of the Serious Incident Management Team (SIMT) at the HSE.
"I would like to thank the patients and their families for the courtesy and understanding shown by them to the hospital staff in the course of this review.
"This cannot have been easy particularly when having to deal with devastating news which would have had a profound effect on them and their families."
"This was the biggest radiology look-back carried out in this country.
"It was carried out very professionally in a very short time period by dedicated hospital staff at UHK who went over and above their normal duties to complete the process as judiciously as possible whilst at the same time keeping the patients at the centre of all efforts and decisions.
"I would also like to express my thanks to the external radiology and medical staff as well as staff in the SSWHG for their support during this process."
Patients who have any concerns following the publication of the look-back review can contact a helpline on 1800-742-900.
This will operate between 9.00am to 9.00pm on Wednesday and 9.00am to 5.00pm from Thursday onwards.