China NMPA Product Recall - X-ray computed tomography equipment

Philips Healthcare (Suzhou) Co., Ltd. initiated a voluntary Class III recall of its X-ray Computed Tomography (CT) equipment, specifically Ingenuity Core 128 and Ingenuity Flex models, with the recall notice published on July 8, 2016. This action, overseen by the National Medical Products Administration (NMPA), addresses a critical product defect concerning the structural integrity of the equipment. The main issue identified is the insufficient strength of the casing material near the Philips logo on the back cover of the patient support unit/scanning bed. This deficiency can lead to cracking if subjected to excessive external force, posing a potential risk of scratches to operators, patients, bystanders, or service personnel. While no adverse events have been reported, Philips Healthcare (Suzhou) Co., Ltd. is implementing proactive corrective measures. Required actions include notifying all affected users via customer notification letter 72800656 and issuing Field Corrective Action (FCO) 72800656. The core action is replacing the defective back cover of the patient support unit on all affected machines. The recall impacts products sold in multiple countries, including Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, China, and the UK.