MalfunctionLMB

RADIMETRICS

Received Sep 10, 2019 · Event occurred Jun 19, 2019

Report 8981078 · MDR key 8981078

Device

Generic name

Device, Digital Image Storage, Radiological

Manufacturer

Bayer Medical Care Inc.

Product problems

Application Program Problem: Dose Calculation Error

Patient

Not reported

No Known Impact Or Consequence To Patient
No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

WE HAVE A RADIATION DOSE MONITORING SYSTEM CALLED RADIMETRICS AND IT IS NOT CALCULATING THE PATIENT ORGAN DOSES CORRECTLY FOR MULTIPLE PATIENTS. IT SEEMS TO BE AN ISSUE WITH THE CONFIGURATION ON THE RADIMETRICS SYSTEM. WE HAVE CONTACTED THE VENDOR AND THEY ARE WORKING ON THE ISSUE.