China NMPA Product Recall - Patient monitor patient monitor

Nippon Kohden Kogyo Co., Ltd., a medical device manufacturer, initiated a voluntary Level II recall of specific models and batches of its Patient Monitor Bed Sid Monolith. This action, reported by Shanghai Optoelectronic Medical Electronic Instruments Co., Ltd., was announced on November 8, 2021, and is overseen by the National Medical Products Administration (NMPA).

The primary issue leading to this recall is a defect within a specific version of the embedded software of the Patient Monitor Bed Sid Monolith. This software is unable to correctly identify information transmitted from the host computer with which the device is used, potentially impacting the accuracy and reliability of patient data monitoring.

As a proactive measure, Nippon Kohden Kogyo Co., Ltd. is recalling the affected devices. A Level II recall signifies that the product's use may cause temporary or medically reversible adverse health consequences, or where the likelihood of serious adverse health consequences is remote. The company is required to provide detailed information on the specific products, specifications, and batch numbers impacted by this recall in a "Medical Device Recall Event Report Form." This voluntary action underscores the company's commitment to patient safety and product quality, operating under the regulatory guidance of the NMPA.