China NMPA Product Recall - LIFEPAK CR PLUS

On November 24, 2016, Physio-Control, Inc., in cooperation with its Chinese responsible unit, Beijing Jietong Kangnuo Pharmaceutical Technology Co., Ltd., initiated a global voluntary Class I recall for its LIFEPAK CR PLUS Automated External Defibrillators. This action was reported to the National Medical Products Administration (NMPA) on November 24, 2016, and publicly announced the following day.

The recall stemmed from the discovery of a critical technical malfunction: an internal component, specifically a reed switch, could intermittently remain in the OFF position after the device cover was opened and the ON/OFF button pressed. This defect prevents the defibrillator from activating crucial voice prompts and delivering a therapeutic electrical shock. Such a failure could render the device ineffective in resuscitating patients experiencing cardiac arrest, thereby posing a significant risk to patient safety and treatment efficacy. At the time of the recall, no patient treatment delays directly attributable to this issue had been reported.

Operating under the NMPA's stringent medical device regulations, a Class I recall indicates a situation with a reasonable probability of serious adverse health consequences or death. As a corrective measure, Physio-Control has notified all affected customers globally. The company is facilitating device calibration for all impacted units, which involves replacing the faulty reed switch assembly or providing alternative, fully functional devices to ensure the continuity of critical patient care.