China NMPA Product Recall - EnCor Breast Biopsy System

The National Medical Products Administration (NMPA) issued a recall notice on April 13, 2016, concerning SenoRx Inc.'s Breast Biopsy and Excision System (EnCor Breast Biopsy System). This voluntary recall, reported by Bard Medical Technology (Shanghai) Co., Ltd. on March 31, 2016, stemmed from a critical labeling error. The product packaging incorrectly stated that an MRI-compatible footswitch (FSENCOREMR) was included, whereas the actual device contained a standard footswitch (FSENCOR01).

The primary concern was the potential for the standard footswitch to be affected by magnetic fields if used in an MRI environment. However, an evaluation concluded that this mislabeling was more likely to result in user dissatisfaction than actual harm to patients or users.

Under the NMPA's regulatory framework, the required actions for all affected products included immediately halting distribution and use, quarantining all recalled units, and circulating recall notifications. Specifically for China, only one unit was imported and was confirmed not to have been distributed within the Chinese market, having been returned. Therefore, no further actions were necessary for products within China, though regional administrations were advised to strengthen supervision.