COLLIMATOR, AUTOMATIC, RADIOGRAPHIC
Received Dec 13, 2024 · Event occurred Oct 23, 2024
Report 1000513161-2024-00039 · MDR key 20929805
Device
Generic name
Collimator, Automatic, Radiographic
Manufacturer
Siemens HealthineersModel number
UNKNOWNCatalog number
UNKNOWN
Lot number
UNKNOWN
Product problems
- Poor Quality Image
- Optical Obstruction
- Poor Quality Image
- Optical Obstruction
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
COMP # (B)(4).
Description of Event or Problem
ON DECEMBER 2ND, 2024, THE FUJIFILM AMERICAS HEALTHCARE CORPORATION RECEIVED A MEDWATCH MW5162227 REPORT REGARDING A POTENTIAL PERFORMANCE ISSUE WITH THE FUJI DEVO SUITE II X-RAY SYSTEM. IT WAS REPORTED THAT A "CUTOFF" IS OBSERVED WHEN THE COLLIMATOR BLADES ARE FULLY OPENED ALONG THE ANODE-TO-CATHODE AXIS OF THE X-RAY TUBE. THE CUTOFF IS SEEN ON THE ANODE SIDE, AND THE AMOUNT OF CUTOFF VARIES DEPENDING ON THE SOURCE-TO-IMAGE DISTANCE (SID). THE AMOUNT OF CUTOFF EXCEEDS THE FDA'S REQUIREMENT OF 2% OF SID. THERE IS NO PATIENT HARM OR INJURY REPORTED AS PER MEDWATCH MW5162227 REPORT.
Additional Manufacturer Narrative
COMP # (B)(4). SUPPLEMENTAL S1 IS SUBMITTED TO UPDATE THE PRODUCT NAME.