MalfunctionLHO
EXRADIN
Received May 27, 2003 · Event occurred May 14, 2003
Report 2184007-2003-00003 · MDR key 469205
Device
Generic name
Ionization Chamber
Manufacturer
Standard Imaging, Inc.Model number
A12Catalog number
92700
Lot number
*
Product problems
- Calibration Error
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
CUSTOMER ALLEGED THAT THE EXRADIN A12 IONIZATION CHAMBER HAS A SIGNIFICANT DIFFERENCE IN THE CALIBRATION FACTOR FROM THAT PROVIDED ON THE CALIBRATION CERTIFICATE FROM THE ACCREDITED DOSIMETRY CALIBRATION LABORATORY (ADCL). THIS DEVICE IS USED FOR THE QUALITY ASSURANCE CHECKS ON RADIATION THERAPY DEVICES.
Remedial action
- Other