6257 XPEDITION HIGH CONFIG

Additional Manufacturer Narrative

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. 1 DEVICE(S) WAS FUNCTIONALLY/VISUALLY INSPECTED IN THE FIELD. THE DEVICE(S) WAS/WERE REPAIRED AND RETURNED TO USE. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS): 1 DEVICE: BELT / DEVICE MIGRATION. THERE WAS NO REMEDIAL ACTION TAKEN. THIS DEVICE IS NOT LABELED FOR SINGLE USE.

Description of Event or Problem

THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. EVENTS OCCURRED BETWEEN JULY 1-SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT(S), WHERE IT WAS REPORTED THE DEVICE EXPERIENCED DIFFICULT TO MANEUVER UNIT WHICH DOES NOT RESULT IN A TIP. NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.

Description of Event or Problem

NO NEW INFORMATION.

Additional Manufacturer Narrative

THE DEVICE THAT WAS PENDING EVALUATION WAS EVALUATED IN THE FIELD AND THE ISSUE WAS CONFIRMED. THE DEVICE WAS REPAIRED ON SITE AND RETURNED TO SERVICE. EVALUATION RESULTS FINDINGS (COMPONENTS/RESULTS). 1 DEVICE: CASTER/MECHANICAL PROBLEM IDENTIFIED.

Additional Manufacturer Narrative

AN ADDITIONAL EVENT WAS IDENTIFIED AND THEREFORE ADDED TO THIS SUMMARY REPORT. THE DEVICE IS PENDING EVALUATION.

Description of Event or Problem

THIS REPORT NOW SUMMARIZES 2 MALFUNCTION EVENT(S), INSTEAD OF 1.