China NMPA Product Recall - Mobile C-arm X-ray machine

Medtronic (Shanghai) Management Co., Ltd. initiated a Class II voluntary recall of its O-arm® mobile C-arm X-ray machines, as reported by the National Medical Products Administration (NMPA) on September 30, 2016. This action stemmed from internal findings by Medtronic Navigation, Inc. (Littleton), the manufacturer, reported on August 15, 2016. The recall affects 19 units sold in China and is global in scope.

The primary issues identified relate to non-compliance with US FDA Federal Regulations Chapter 21. Specifically, technical information within the user manuals of the affected O-arm 1000 models contained terminology discrepancies. Furthermore, the production and maintenance documentation lacked the required specification for air kerma rate and cumulative air kerma display accuracy, which federal regulations mandate be determined by the number of radiation exposures. An additional concern involved internal process inconsistencies that could lead to insufficient control over battery replacement shipments and a risk of undetected battery damage due to improper packaging during transport. Medtronic emphasized that no user injuries had been reported as a result of these issues.

To address these concerns, Medtronic is undertaking several corrective actions. The company will issue notification letters to all affected hospitals. Engineers will conduct on-site equipment testing to inspect X-ray generators and batteries, and verify air kerma accuracy against federal standards. Moreover, Medtronic plans to revise system manuals and, following regulatory approval, provide updated manual forms and software upgrades to hospital equipment. This corrective action does not involve product returns.