China NMPA Product Recall - Dental X-ray machine

Carestream Asia Pacific Investment Management (Shanghai) Co., Ltd., representing manufacturer Carestream Health Inc., initiated a voluntary Class II recall for specific dental X-ray machine models (CS 8100, CS 8100 Access, CS 8100 3D). This recall, reported to the National Medical Products Administration (NMPA) on January 27, 2015, and published on February 15, 2015, pertains to products manufactured between June 2012 and September 2014, operating under CFDA (Imported) No. 20133304996.

The core issue identified was a manufacturing defect: the absence of a spring ring (fixing clip) on the locating pin intended to secure the equipment's column. This omission could lead to the dental X-ray machine's head assembly accidentally sliding down, posing a potential safety risk to patients. Although only one global incident has been reported with no resulting injuries, the defect signifies a risk of unexpected movement or misalignment during operation.

Carestream's corrective measures involve comprehensive customer and agent notification regarding the affected product range and potential problems. The company will dispatch authorized service personnel to conduct complimentary on-site inspections of the equipment. Any units found to require preventative corrective measures or maintenance services will receive these repairs free of charge to fully resolve the manufacturing flaw and ensure the device's intended performance throughout its lifecycle.