NUCART
Received Jun 17, 2026 · Event occurred Jun 10, 2026
Report 3009028104-2026-00001 · MDR key 25540894
Device
Product problems
- Unstable
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
OUR CUSTOMER REPORTED THAT A NUCART SYSTEM STARTED TO TIP OVER DURING A MEDICAL PROCEDURE. STAFF CAUGHT THE SYSTEM BEFORE IT HIT THE GROUND AND SECURED IT UPRIGHT. NO ONE WAS HURT AND THERE WAS NO DAMAGE. THE DEVICE WAS REMOVED FROM SERVICE AND REPAIRED ON (B)(6) 2026.
Additional Manufacturer Narrative
ONDAL DETERRMINED THAT REVISION CHANGES OF 2 SEPARATE COMPONENTS CREATES A TIP HAZARD IN THE MEDICAL DEVICE. AN EARLY REVISION OF A LIFT POST, NO LONGER IN PRODUCTION, WHEN COMBINED WITH THE UPGRADED VERSION OF THE ACCOMPANYING LIFT PLATE CREATED AN UNSTABLE PLATFORM. WE IDENTIFIED POTENTIAL UNITS WITH THIS COMBINATION. WE IMMEDIATELY PROVIDED A TEST PROCEDURE TO DETECT THE DEFECTIVE UNITS AND PROVIDED THIS TO OUR CUSTOMERS. WE ARE REPAIRING IMPACTED UNITS IN THE FIELD.
Remedial action
- Repair