A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
Reason for recall: A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment. Distribution: Worldwide - US Nationwide distribution in the state of PA and the countries of Australia, Czech Republic, Finland, France, Germany, Israel, Italy, Japan, New Zealand, Norway, Poland, Qatar Spain, Sweden, Switzerland, UK. Quantity: 25 units Lot/code info: (1) Model/Catalog Number: 1430116; UDI-DI: TBD; (2) Model/Catalog Number: 1430117; UDI-DI: TBD; (3) Model/Catalog Number: 1430115; UDI-DI: TBD;
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.