GE LUNAR BONE DENSITOMETER
Received May 5, 2025 · Event occurred Apr 21, 2025
Report MW5169944 · MDR key 21961221
Device
Generic name
Densitometer, Bone
Model number
LUNARProduct problems
- Failure of Device to Self-Test
- Manufacturing, Packaging or Shipping Problem
- Therapeutic or Diagnostic Output Failure
- Fail-Safe Did Not Operate
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
I AM FORMALLY ESCALATING A CRITICAL SERVICE AND RADIATION SAFETY ISSUE INVOLVING A NEWLY PURCHASED GE LUNAR BONE DENSITOMETER (SERIAL #: (B)(6)) THAT HAS EXHIBITED REPEATED CRITICAL FAILURES, CULMINATING IN A COLLIMATOR MALFUNCTION AND EXTENDED CLINICAL DOWNTIME. TIMELINE OF ISSUES: 9/26/2024: MACHINE WAS LOST BY SHIPPER AND MISTAKENLY DELIVERED TO DELL COMPUTERS. OUR TEAM HAD TO LOCATE THE MACHINE. ON 12/16/2024 (CASE (B)(4)): FAILED QA; TRANSVERSE MOTION ERROR; BELT REPLACED ONSITE. ON 3/5/2025 (CASE (B)(4)): FAILED QA; QA MEANS RESET; OPERATIONAL SAME DAY. ON 4/22/2025 (CURRENT CASE OPEN): FAILED QC FOR COLLIMATOR O CIRCUIT BOARD AND COLLIMATOR WERE REPLACED; SYSTEM REMAINS NON-FUNCTIONAL. AS OF APRIL 29, 2025, THE MACHINE HAS BEEN DOWN FOR 8 CALENDAR DAYS (6 FULL BUSINESS DAYS) WITHOUT SUCCESSFUL REPAIR. MAJOR SERVICE AND WARRANTY FAILURES: RADIATION SAFETY RISK: COLLIMATOR FAILURE COMPROMISES BEAM RESTRICTION. NO DOCUMENTATION VERIFYING POST-FAILURE RADIATION CONTAINMENT HAS BEEN PROVIDED. MECHANICAL RELIABILITY FAILURE: REPEATED QA FAILURES AND HARDWARE BREAKDOWNS HAVE DELAYED PATIENT CARE.